BLAZER™ II XP

Indications for Use

The EP Technologies Cardiac Ablation System is indicated for treatment of sustained or recurrent, Type 1 atrial flutter, clockwise or counter clockwise.

Contraindications

Use of the device is contraindicated for patients with active systemic infection. The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Warnings

Before operating the device, read these warnings carefully:

• Use lower Power First - When first delivering RF energy, begin by using a low power setting (i.e., 50W). If the created lesion is unsuccessful or inadequate, incrementally increase the power output with successive ablation attempts to minimize the potential for thrombus formation and/or inadvertent damage to cardiac tissues.
• Always minimize exposure to ionizing radiation due to fluoroscopy. Because the long-term effects of exposure to ionizing radiation are unknown, careful consideration should therefore be given to pregnant women and pre-pubescent children.
• Pacemakers and implantable cardioverter/defibrillators can be adversely affected by RF signals. It is important to: a) Retain temporary external sources of pacing available during ablation. b) Reprogram the pacing system temporarily to minimum output or 000 mode to minimize risk of inappropriate pacing. c) Exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent pacing leads. d) Perform complete pacing system analysis on all patients after ablation.
• Implanted cardioverter/defibrillators should be deactivated during delivery of RF power.
• The Steerable Ablation Catheters are intended for single patient use only. Do not reprocess or reuse. Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another.
• 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 positioned in the chordae tendinae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue.
• Patients undergoing AV nodal modification or ablation of septal accessory pathways are at risk for inadvertent AV block. It is advisable to use lower initial power in such patients and to monitor anterior conduction closely during RF power delivery.
• During a transaortic approach, adequate fluoroscopic visualization is necessary to avoid placement of the ablation catheter within the coronary vasculature. Catheter placement and RF power application within the coronary artery has been associated with myocardial infarction and death.
• In the presence of anticoagulation, there may be an increased risk of bleeding from all causes.
• The catheter is supplied sterile in a sealed package. Prior to use, carefully inspect the package for any breach of the sterile seal. Do not use if there is damage to either the package or product.

Precautions

Observe these precautions, before using the device:

• The EP Technologies XP Cardiac Ablation Catheters are intended for use with the Controller and accessories only.
• Peri-procedural anticoagulation therapy is recommended for patients undergoing left-sided and transseptal cardiac procedures and should be considered for selected patients undergoing right-sided procedures.
• The Blazer II XP™ Catheter is highly torqueable. Avoid overtorquing. 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 degrees). 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.
• Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be done under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
• Excessive bending or kinking of the catheter shaft may damage internal wires. Manual prebending of the distal curve can damage the steering mechanism and may cause patient injury.
• Cardiac ablation procedures should be performed only by physicians thoroughly trained in the techniques of RF Powered Catheter Ablation in a fully-equipped electrophysiology laboratory.
• The IMPEDANCE Display of the Controller should be continuously monitored during RF power delivery. If a sudden rise in impedance is noted, power delivery should be discontinued. The Catheter should be removed and the distal tip of the Catheter cleaned to eliminate any coagulum.
• Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram (ECG) during radiofrequency power applications.
• When using XP Catheters, it is required that two Disposable Indifferent Patch Electrode Pads satisfying the requirements of ANSI/AAMI Standard HF-18 be used as the ablation return electrodes or skin burns may result. Use of only one DIP electrode will not allow the operator to fully access the higher power capabilities of the Controller.
• Read and follow the Disposable Indifferent (Dispersive) Patch (DIP) Electrode manufacturer's instructions for use; the use of DIP Electrodes which meet or exceed ANSI/AAMI HF-18 requirements is required.
• Placement of the dispersive electrodes on the thigh could be associated with higher impedance, which could result in automatic RF power shut-off.
• During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces.
• Apparent low power output or failure of the equipment to function correctly at normal settings may indicate faulty application of the DIP electrodes or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication.
• The risk of igniting flammable gases or other materials is inherent in the application of RF power. Precautions must be taken to restrict flammable materials from the ablation site. Electromagnetic interference (EMI) produced by the Controller during the delivery of RF power may adversely affect the performance of other equipment.
• Regularly inspect and test re-usable cables and accessories.

Adverse Events

The following potential risks or discomforts may be associated with cardiac ablation:

• Death
• Stroke
• Myocardial Infarction
• Pulmonary edema
• Vessel thrombus
• Hematoma/bruising
• Infection
• Allergic reaction
• Skin Burns
• Cardiac/Respiratory Arrest
• Pericarditis
• Pseudoaneurysm
• Vascular or heart damage
• Perforation or tamponade
• Endocarditis
• Abnormal heart rhythms
• Heart valve damage
• Radiation exposure (from X-trays)
• Catheter entrapment
• AV/SA Node damage that may result in transient or permanent heart block that may or may not require a pacemaker.
• Bleeding
• Chest Discomfort
• Hemoptysis
• Phrenic nerve damage
• Vaso Vagal reaction
• Hypotension
• Aspiration
• Pericardial/pleral effusion

Cautions

Federal (USA) law restricts these devices to sale by or on the order of a physician. Carefully read all instructions prior to use.