BLAZER™ II, BLAZER II HTD and BLAZER II XP

Indications, Safety and Warnings

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

BLAZER II and BLAZER II HTD Temperature Ablation Catheter

INDICATIONS FOR USE
When using the BLAZER II/BLAZER II HTD Catheters: The Boston Scientific Cardiac Ablation System is indicated for creating endocardial lesions during cardiac ablation procedures to treat arrhythmia.

CONTRAINDICATIONS
The BLAZER II and BLAZER II HTD Catheters are contraindicated for use:
• in patients with active systemic infection.
• in patients with a mechanical prosthetic heart valve through which the catheter must pass.
• in patients with conditions where insertion into or manipulation in the cardiac chambers is unsafe as these conditions (e.g., presence of intracardiac thrombus or myxoma, history of recent cardiac surgery with atriotomy, etc.) may increase the risk of systemic embolism or cardiac perforation.
• in patients who are unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.
• in patients who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach.
• in patients who are hemodynamically unstable.
• in patients with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe, such as but not limited to, a recent previous cardiac surgery (e.g., ventriculostomy or atriotomy, Coronary Artery Bypass Graft [CABG], PTCA/PCI/coronary stent procedure/unstable angina) an/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g. severe rotational anomalies of the heart or great vessels);
• via transseptal approach in patients with an intra-atrial baffle or a foramen ovale patch.
• via retrograde transaortic approach in patients with a prosthetic aortic valve.
Do not use this device:
• with a long sheath or a short introducer < 8F.
• in the coronary vasculature.

WARNINGS

o PPMs, ICDs, and leads can be adversely affected by ablation energy. It is important to refer to the device manufacturer’s instruction for use prior to performing ablation procedures.
o Do not apply RF energy directly to a lead or to tissue immediately in contact with a lead because it could potentially damage the lead or lead function.
o Temporarily reprogram the pacemaker or defibrillator per the manufacturer guidelines during ablation. The device could be damaged by the ablation procedure. Interrogate the device fully after the ablation per the manufacturer guidelines and reprogram to preoperative sensing and pacing parameters.
o Program the ICD Tachy therapy to “Off” to prevent inappropriate shock and/or possible damage to the device from the ablation procedure. Remember to turn Tachy Therapy to “On” once ablation is complete.
o Have temporary external sources of pacing and defibrillation available.
o Perform a complete analysis of the implanted device function after ablation.
o Fluoroscopic or appropriate imaging guidance and care must be taken during catheter advancement, manipulation, and withdrawal to avoid lead dislodgement.
o Monitor pre- and post-measurements for sensing and pacing thresholds and impedances to determine the integrity of the lead-patient function.

• Do not ablate from within the coronary artery as the resulting myocardial injury can be fatal. Adequate visualization techniques, such as fluoroscopy or intracardiac echocardiography, are necessary during the transaortic approach to avoid placement of the ablation catheter in the coronary vasculature.
• During RF ablation, care must be taken not to deliver RF energy on or near the coronary artery even on the right side of the heart, as the resulting myocardial injury can be fatal.
• Ablation in contact with any other electrodes alters the function of the catheter and can lead to thrombus, coagulum, or char formation that may result in embolism.
• At no time should an BLAZER II or BLAZER II HTD Catheter be advanced or withdrawn when resistance is felt, without determining the cause. Valve damage, vascular and/or cardiac perforation is a risk with any intracardiac catheter.
• Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures. The potential for catheter entrapment may be increased when the catheter is over torqued and/or positioned in the chordae tendineae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue and/or valve damage.
• Do not use the BLAZER II or BLAZER II HTD ablation system in the proximity of Magnetic Resonance Imaging (MRI) equipment because the MRI equipment may adversely impact the function of an RF Controller and the ablation system may adversely impact the image quality. This can also lead to loss of visibility during ablation which can cause patient injuries such as perforation, heart block and injury to adjacent structures.
• Catheter ablation procedures present the potential for significant radiation exposure, which can result in acute radiation injury as well as an increased risk for somatic and genetic effects, to both patients and laboratory staff due to the radiation beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps have been taken to minimize this exposure. Due to radiation exposure during catheter ablation, the safety and effectiveness of this device has not yet been established in pregnant and/or nursing women and pediatric patients.
• There are no data to support the safety and effectiveness of this device in the pediatric population.
• Excessive curves or kinking of the catheter may damage internal wires and components. This damage may affect steering performance and may cause patient injury.
• Use both fluoroscopy, or other visualization technique such as echocardiography, and electrograms to monitor the advancement of the catheter to the area of the endocardium under investigation to avoid conduction pathway injury, cardiac perforation or tamponade.
• Do not deliver RF energy with the catheter outside the target site. RF Controllers can deliver significant electrical energy and may cause patient injury.
• In the event of a generator cut-off (impedance or temperature), the catheter must be withdrawn and the tip electrode cleaned of coagulum before RF energy is reapplied.
• Verify effective contact between the patient and the Dispersive Pad whenever the patient is repositioned as patient movement may disrupt Dispersive Pad contact resulting in patient injury and/or extended procedure times.
• Patients with hemodynamic instability or cardiogenic shock are at increased risk for life-threatening adverse events and ablation must be done with extreme caution.
• The BLAZER II and BLAZER II HTD Catheters are not intended to be used for internal cardioversion. Doing so may result in perforation, arrhythmias, embolism, thrombus and/or patient death.
• The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
• If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the procedure, there should be a low threshold to perform a Transesophageal Echocardiogram (TEE) prior to the procedure to confirm absence of mural thrombus and/or thrombus in the left atrial appendage.
• There are no safety and effectiveness data with this catheter for left-sided atrial flutter and/or pulmonary vein isolation for atrial fibrillation.
• Do not pass the BLAZER II or BLAZER II HTD Catheter through any prosthetic heart valve (mechanical or tissue), as this may cause entrapment of the catheter and/or damage to the prosthetic heart valve, resulting in valvular insufficiency and/or premature failure of the prosthetic valve.
• Do not deliver RF energy when the tip electrode is withdrawn or partially withdrawn into a sheath, to minimize the risk of char or coagulum formation.
• Guiding catheters and/or long introducer sheaths present the potential for thromboembolic events. Pre-flush and maintain lumen patency with heparinized intravenous infusion.
• Do not wipe this catheter with organic solvents such as alcohol or immerse the handle cable connector in fluids. This may result in electrical or mechanical catheter failures. It may also result in an allergic reaction from the patient.
• Pre-procedural anticoagulation therapy is at the discretion of the physician. However, patients with a history of thromboembolic events may require therapeutic anticoagulation therapy, pre-, during and post-ablation to reduce the incidence of major complications. Peri-procedural anticoagulation therapy should be administered per institutional standards.
• The safety and/or efficacy of epicardial use of the BLAZER II and BLAZER II HTD Catheters has not been evaluated in a clinical trial.
• Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the relevant local regulatory authority.

PRECAUTIONS
• The BLAZER II and BLAZER II HTD Catheters are designed for use with the BSC RF Controllers and accessories only.
• Use only sterile saline and gauze pad to clean the tip.
• Equipment/accessories carrying high frequency alternating current may cause direct coupled interference and, therefore, may disrupt the operation of the RF Controller. It may be necessary to take risk control measures, such as re-orienting, relocating, or shielding the interfering equipment/accessories.
• Use only Dispersive Pads that meet or exceed IEC 60601-2-2 requirements and follow the dispersive pad manufacturer’s instructions for use. The use of dispersive pads which meet ANSI/AAMI requirements (HF18) is recommended.
• Apparent low power output, high impedance reading or failure of the equipment to function correctly at normal settings may indicate faulty application of the Dispersive Pad or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication.
• The BLAZER II and BLAZER II HTD Catheters are highly torqueable. Avoid over-torquing. Over-rotating the handle and catheter shaft may cause damage to the distal tip or catheter assembly. Do not rotate the handle and catheter shaft more than one and one-half times the full rotation (540°). If the desired catheter tip position is not achieved, adjust the catheter’s curve to disengage the catheter tip from the heart wall before resuming rotation of the handle and catheter shaft.
• Electrophysiology catheters and systems are intended for use only in radiation shielded rooms due to electromagnetic compatibility requirements and other hospital safety guidelines.
• The risk of igniting flammable gases or other materials is inherent in electrosurgery. Precautions must be taken to restrict flammable materials from the electrosurgical suite.
• If the temperature is low, does not rise, or suddenly drops, discontinue RF delivery, adjust catheter position to improve contact and stability then reinitiate RF delivery.
• Adequate filtering must be used to allow continuous monitoring of the surface Electrocardiogram (ECG) during RF power applications.
• When crossing the aortic valve with the ablation catheter, it is recommended that the catheter tip be deflected to resemble a “pigtail” curve to avoid damage to the valve leaflets.
• It is recommended not to exceed thirty (30) radiofrequency power applications per catheter.

POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the use of the BLAZER II and II HTD Catheters include, but are not limited to:
• Pain or discomfort, for example:

o Angina
o Chest pain
o Non-cardiovascular pain

• Cardiac arrest
• Death
• Electric shock
• Hypertension
• Hypotension
• Infection/inflammation (including pericarditis and pleuritis)/exposure to biohazardous material
• Edima/heart failure/pleural effusion
• Procedural related side effects, for example:

o Allergic reaction (including anaphylaxis)
o Genitourinary complication
o Side effects related to medication or anesthesia
o Radiation injury/tissue burn
o Renal failure/insufficiency
o Vasovagal response
o Fluid volume overload

• Respiratory/distress/insufficiency/failure/dyspnea
• Arrhythmia (new or exacerbated)

o Conduction pathway injury (heart block, nodal injury, etc.)

• Nerve injury, for example:

o Phrenic nerve injury
o Vagal nerve injury

• Gastrointestinal disorders
• Vessel trauma, including:

o Perforation
o Dissection
o Coronary artery injury
o Vasospasm
o Occlusion
o Hemothorax

• Cardiac trauma, for example:

o Cardiac perforation/cardiac tamponade/pericardial effusion
o Valvular damage
o Still left atrial syndrome

• Injury related to tissue damage and/or adjacent structures, for example:

o Esophageal injury
o Pulmonary injury
o Catheter entrapment
o Physical trauma

• Fistula, for example:

o Atrio-esophageal fistula
o Bronchopericardial fistula

• PV stenosis and its symptoms, for example:

o Cough
o Shortness of breath
o Fatigue
o Hemoptysis

• Surgical and access complications, for example:

o Hematoma/seroma
o AV fistula
o Bleeding
o Pseudoaneurysm
o Pneumothorax
o Residual atrial spetal defect

• Thrombosis
• Injury due to embolism/thromboembolism/air embolism/foreign body embolism

o Cerebrovascular Accident (CVA)/stroke
o Transient Ischemic Attack (TIA)
o Myocardial infarction
o Neurological impairment and its symptoms, for example:

o Cognitive changes, visual disturbances, headache, motor impairment, sensory impairment, and speech impairment

• Pulmonary embolism
• Asymptomatic cerebral embolism
The potential adverse events may be related to the ablation catheter(s) and/or the interventional procedure. The severity and/or frequency of these potential adverse events may vary and may result in prolonged procedure time and/or additional medical and/or surgical intervention, implantation of a permanent device such as a pacemaker, and in rare cases, may result in death.

90960888 (Rev AD.6)

BLAZER II XP Temperature Ablation Catheter

INDICATIONS FOR USE

The BSC BLAZER II XP Catheter is indicated for use with the Controller and Accessories for the treatment of sustained or recurrent type I atrial flutter in patients age 18 or older. The Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

CONTRAINDICATIONS

The BLAZER II XP Catheter is contraindicated for use:
• in patients with active systemic infection;
• in patients with a mechanical prosthetic heart valve through which the catheter must pass;
• in patients with conditions where insertion into or manipulation in the cardiac chambers is unsafe as these conditions (e.g., presence of intracardiac thrombus or myxoma, history of recent cardiac surgery with atriotomy, etc.) may increase the risk of systemic embolism or cardiac perforation;
• in patients who are unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation;
• in patients who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach;
• in patients who are hemodynamically unstable;
• in patients with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe, such as but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, Coronary Artery Bypass Graft [CABG], PTCA/PCI/coronary stent procedure/unstable angina) an/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g. severe rotational anomalies of the heart or great vessels);
• via transseptal approach in patients with an intra-atrial baffle or a foramen ovale patch;
• via retrograde transaortic approach in patients with a prosthetic aortic valve.
Do not use this device:
• with a long sheath or a short introducer < 8F.
• in the coronary vasculature.

WARNINGS

• If the visibility of the EP catheters is compromised for any reason, the user should stop and not resume ablation therapy until catheter visibility is established in order to prevent patient injuries such as perforation, heart block and injury to adjacent structures.
• Cardiac mapping and ablation procedures should be performed only by physicians thoroughly trained in invasive cardiology, in the techniques of mapping and RF ablation, and in the specific approach to be used, in a fully-equipped electrophysiology lab.
• Administer appropriate levels of peri-procedural anticoagulation therapy for selected patients undergoing right-sided procedures. Administer anticoagulation therapy during and post-procedure according to institution standards to minimize bleeding and thrombotic complications.
• Carefully read all equipment and ancillary device instructions required for the procedure prior to use. Observe all contraindications, warnings, and precautions noted in these instructions. Failure to do so may result in patient complications.
• Before using, inspect the BLAZER II XP Catheter for any defects or physical damage, including electrical insulation on the cables and the catheter shaft that, if used, may cause patient and/or user injury. Do not use defective or damaged devices. Replace damaged equipment if necessary. No modification of this equipment is allowed.
• Electromagnetic Interference (EMI) from any source during normal operation may adversely affect the visualization and tracking of the catheter during the procedure, which can cause patient injuries such as perforation, heart block and injury to adjacent structures.
• Titrate RF as specified in the Operational Instructions section. Too rapid an increase in power during ablation may lead to perforation, arrhythmias, damage to adjacent structures, and/or embolism.
• Collateral tissue damage is a possibility when using the ablation catheter at the upper power setting (100 watts) with a duration longer than 60 seconds or with a decrease in impedance without moving the tip of the ablation catheter.
• The BLAZER II XP Catheter are not intended to be used with an RF Controller output setting exceeding 100 watts or 290 Vpk. The safety and performance of the BLAZER II XP Catheter at powers exceeding 100 watts has not been evaluated in a clinical trial. Exceeding the recommended power settings may increase the risk of patient injury.
• Patients who have had a prior atrial flutter ablation procedure may be at greater risk for perforation and/or pericardial effusion with the use of this catheter system.
• Patients undergoing septal accessory pathway, Atrioventricular (AV) node reentry tachycardia, and/or atrial flutter ablation are at risk for complete AV block which requires the implantation of a temporary and/or permanent pacemaker.
• During energy delivery, the patient should not be allowed to come in contact with grounded metal surfaces to minimize the potential for electrical shock.
• Ensure that the cable/catheter connection remains dry throughout the procedure in order to prevent electric shock or other patient injuries as well as to prevent loss of device function.
• Electrodes and stimulating devices can provide paths of high frequency current. The risk of burns can be reduced but not eliminated by placing the electrodes as far away as possible from the ablation site and the Dispersive Pad. Protective impedances may reduce the risk of burns and permit continuous monitoring of the Electrocardiogram (ECG) during energy delivery.
• Fibrin may accumulate in or on the sheath/catheter assembly during the procedure. Aspirate when removing the dilator or catheter.
• In the presence of anticoagulation, there may be an increased risk of bleeding from all causes.
• Electrical recording or stimulation equipment must be isolated. Current leakage from any electrical equipment that is connected to the patient must not exceed 10 microamps for intracardiac electrodes.
• Care must be taken to ensure that any equipment used in connection with the BSC catheters be type CF, be defibrillation proof, meet IEC 60601-1 electrical safety requirements, and comply with all local regulatory requirements for specified intended use to reduce the potential risk of inadvertent electrical shock.
• Do not insert or withdraw the BLAZER II XP Catheter without straightening the catheter tip (returning the steering lever to neutral position) in order to prevent entanglement/entrapment within the valve and/or other device that may result in myocardial trauma and/or may require additional medical/surgical intervention.
• Stimulation of cardiac tissues caused by pacing stimulus and/or RF energy may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns.
• Maximum Catheter Rated Voltage: 290 Vpk
• Warnings for patients with implantable pacemakers (PPMs) and Implantable Cardioverter Defibrillators (ICDs):
• PPMs, ICDs, and leads can be adversely affected by ablation energy. It is important to refer to the device manufacturer’s instruction for use prior to performing ablation procedures.
• Do not apply RF energy directly to a lead or to tissue immediately in contact with a lead because it could potentially damage the lead or lead function.
• Temporarily reprogram the pacemaker or defibrillator per the manufacturer guidelines during ablation. The device could be damaged by the ablation procedure. Interrogate the device fully after the ablation per the manufacturer guidelines and reprogram to preoperative sensing and pacing parameters.
• Program the ICD Tachy therapy to “Off” to prevent inappropriate shock and/or possible damage to the device from the ablation procedure. Remember to turn Tachy Therapy to “On” once ablation is complete.
• Have temporary external sources of pacing and defibrillation available.
• Perform a complete analysis of the implanted device function after ablation.
• Fluoroscopic or appropriate imaging guidance and care must be taken during catheter advancement, manipulation, and withdrawal to avoid lead dislodgement.
• Monitor pre- and post-measurements for sensing and pacing thresholds and impedances to determine the integrity of the lead-patient function.
• Do not ablate from within the coronary artery as the resulting myocardial injury can be fatal. Adequate visualization techniques, such as fluoroscopy or intracardiac echocardiography, are necessary during the transaortic approach to avoid placement of the ablation catheter in the coronary vasculature.
• During RF ablation, care must be taken not to deliver RF energy on or near the coronary artery even on the right side of the heart, as the resulting myocardial injury can be fatal.
• Ablation in contact with any other electrodes alters the function of the catheter and can lead to thrombus, coagulum, or char formation that may result in embolism.
• At no time should an BLAZER II XP Catheter be advanced or withdrawn when resistance is felt, without determining the cause. Valve damage, vascular and/or cardiac perforation is a risk with any intracardiac catheter.
• Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures. The potential for catheter entrapment may be increased when the catheter is over torqued and/or positioned in the chordae tendineae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue and/or valve damage.
• Do not use the BLAZER II XP ablation system in the proximity of Magnetic Resonance Imaging (MRI) equipment because the MRI equipment may adversely impact the function of an RF Controller and the ablation system may adversely impact the image quality. This can also lead to loss of visibility during ablation which can cause patient injuries such as perforation, heart block and injury to adjacent structures.
• Catheter ablation procedures present the potential for significant radiation exposure, which can result in acute radiation injury as well as an increased risk for somatic and genetic effects, to both patients and laboratory staff due to the radiation beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps have been taken to minimize this exposure. Due to radiation exposure during catheter ablation, the safety and effectiveness of this device has not yet been established in pregnant and/or nursing women and pediatric patients.
• There are no data to support the safety and effectiveness of this device in the pediatric population.
• Excessive curves or kinking of the catheter may damage internal wires and components. This damage may affect steering performance and may cause patient injury.
• Use both fluoroscopy, or other visualization technique such as echocardiography, and electrograms to monitor the advancement of the catheter to the area of the endocardium under investigation to avoid conduction pathway injury, cardiac perforation or tamponade.
• Do not deliver RF energy with the catheter outside the target site. RF Controllers can deliver significant electrical energy and may cause patient injury.
• In the event of a generator cut-off (impedance or temperature), the catheter must be withdrawn and the tip electrode cleaned of coagulum before RF energy is reapplied.
• Verify effective contact between the patient and the Dispersive Pad whenever the patient is repositioned as patient movement may disrupt Dispersive Pad contact resulting in patient injury and/or extended procedure times.
• Patients with hemodynamic instability or cardiogenic shock are at increased risk for life-threatening adverse events and ablation must be done with extreme caution.
• The BLAZER II XP Catheters are not intended to be used for internal cardioversion. Doing so may result in perforation, arrhythmias, embolism, thrombus and/or patient death.
• The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
• If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the procedure, there should be a low threshold to perform a Transesophageal Echocardiogram (TEE) prior to the procedure to confirm absence of mural thrombus and/or thrombus in the left atrial appendage.
• There are no safety and effectiveness data with this catheter for left-sided atrial flutter and/or pulmonary vein isolation for atrial fibrillation.
• Do not pass the BLAZER II XP Catheter through any prosthetic heart valve (mechanical or tissue), as this may cause entrapment of the catheter and/or damage to the prosthetic heart valve, resulting in valvular insufficiency and/or premature failure of the prosthetic valve.
• Do not deliver RF energy when the tip electrode is withdrawn or partially withdrawn into a sheath, to minimize the risk of char or coagulum formation.
• Guiding catheters and/or long introducer sheaths present the potential for thromboembolic events. Pre-flush and maintain lumen patency with heparinized intravenous infusion.
• Do not wipe this catheter with organic solvents such as alcohol or immerse the handle cable connector in fluids. This may result in electrical or mechanical catheter failures. It may also result in an allergic reaction from the patient.
• Pre-procedural anticoagulation therapy is at the discretion of the physician. However, patients with a history of thromboembolic events may require therapeutic anticoagulation therapy, pre-, during and post-ablation to reduce the incidence of major complications. Peri-procedural anticoagulation therapy should be administered per institutional standards.
• The safety and/or efficacy of epicardial use of the BLAZER II XP Catheters has not been evaluated in a clinical trial.
• Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the relevant local regulatory authority.

PRECAUTIONS

• The BLAZER II XP Catheter is designed for use with the BSC high power Controllers and accessories only.
• Use only sterile saline and gauze pad to clean the tip.
• Equipment/accessories carrying high frequency alternating current may cause direct coupled interference and, therefore, may disrupt the operation of the RF Controller. It may be necessary to take risk control measures, such as re-orienting, relocating, or shielding the interfering equipment/accessories.
• Use only Dispersive Pads that meet or exceed IEC 60601-2-2 requirements and follow the dispersive pad manufacturer’s instructions for use. The use of dispersive pads which meet ANSI/AAMI requirements (HF18) is recommended.
• Apparent low power output, high impedance reading or failure of the equipment to function correctly at normal settings may indicate faulty application of the Dispersive Pad or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication.
• The BLAZER II XP Catheters are highly torqueable. Avoid over-torquing. Over-rotating the handle and catheter shaft may cause damage to the distal tip or catheter assembly. Do not rotate the handle and catheter shaft more than one and one-half times the full rotation (540°). If the desired catheter tip position is not achieved, adjust the catheter’s curve to disengage the catheter tip from the heart wall before resuming rotation of the handle and catheter shaft.
• Electrophysiology catheters and systems are intended for use only in radiation shielded rooms due to electromagnetic compatibility requirements and other hospital safety guidelines.
• The risk of igniting flammable gases or other materials is inherent in electrosurgery. Precautions must be taken to restrict flammable materials from the electrosurgical suite.
• If the temperature is low, does not rise, or suddenly drops, discontinue RF delivery, adjust catheter position to improve contact and stability then reinitiate RF delivery.
• Adequate filtering must be used to allow continuous monitoring of the surface Electrocardiogram (ECG) during RF power applications.
• When crossing the aortic valve with the ablation catheter, it is recommended that the catheter tip be deflected to resemble a “pigtail” curve to avoid damage to the valve leaflets.

POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the use of the BLAZER II XP Catheter include, but are not limited to:
• Pain or discomfort, for example:
• Angina
• Chest pain
• Non-cardiovascular pain
• Cardiac arrest
• Death
• Electric shock
• Hypertension
• Hypotension
• Infection/inflammation (including pericarditis and pleuritis)/exposure to biohazardous material
• Edima/heart failure/pleural effusion
• Procedural related side effects, for example:
• Allergic reaction (including anaphylaxis)
• Genitourinary complication
• Side effects related to medication or anesthesia
• Radiation injury/tissue burn
• Renal failure/insufficiency
• Vasovagal response
• Fluid volume overload
• Respiratory/distress/insufficiency/failure/dyspnea
• Arrhythmia (new or exacerbated)
• Conduction pathway injury (heart block, nodal injury, etc.)
• Nerve injury, for example:
• Phrenic nerve injury
• Vagal nerve injury
• Gastrointestinal disorders
• Vessel trauma, including:
• Perforation
• Dissection
• Coronary artery injury
• Vasospasm
• Occlusion
• Hemothorax
• Cardiac trauma, for example:
• Cardiac perforation/cardiac tamponade/pericardial effusion
• Valvular damage
• Still left atrial syndrome
• Injury related to tissue damage and/or adjacent structures, for example:
• Esophageal injury
• Pulmonary injury
• Catheter entrapment
• Physical trauma
• Fistula, for example:
• Atrio-esophageal fistula
• Bronchopericardial fistula
• PV stenosis and its symptoms, for example:
• Cough
• Shortness of breath
• Fatigue
• Hemoptysis
• Surgical and access complications, for example:
• Hematoma/seroma
• AV fistula
• Bleeding
• Pseudoaneurysm
• Pneumothorax
• Residual atrial septal defect
• Thrombosis
• Injury due to embolism/thromboembolism/air embolism/foreign body embolism
• Cerebrovascular Accident (CVA)/stroke
• Transient Ischemic Attack (TIA)
• Myocardial infarction
• Neurological impairment and its symptoms, for example:
• Cognitive changes, visual disturbances, headache, motor impairment, sensory impairment, and speech impairment
• Pulmonary embolism
• Asymptomatic cerebral embolism

The potential adverse events may be related to the ablation catheter(s) and/or the interventional procedure. The severity and/or frequency of these potential adverse events may vary and may result in prolonged procedure time and/or additional medical and/or surgical intervention, implantation of a permanent device such as a pacemaker, and in rare cases, may result in death.

92289652 B.3

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