WOVEN™ and WOVEN Flexie™ Fixed Curve Diagnostic Electrode Catheter

INTENDED USE/INDICATIONS FOR USE

Woven and WovenFlexie Diagnostic Electrode Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

CONTRAINDICATIONS

The Woven and WovenFlexie Diagnostic Electrode Catheters are contraindicated in patients:

•  with conditions where manipulation of the catheter would be unsafe (e.g., intracardiac mural thrombus);
•  with active systemic infection;
•  with echocardiographically confirmed visual presence of thrombus or myxoma;
• with an interatrial baffle patch or a patent foramen occlusion device for the transseptal approach;
•  with a mechanical prosthetic heart valve through which the catheter must pass;
• with aortic valve replacement via a retrograde transaortic approach;
• with vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral
  approach; and/or
• with any of the Woven and WovenFlexie Diagnostic Electrode Catheters inserted, a need to undergo imaging inside a Magnetic Resonance Imager (MRI).

WARNINGS

• Cardiac mapping procedures should be performed only by physicians thoroughly trained in the techniques of intracardiac electrophysiology, catheter mapping and pacing, and in the specific approach to be used, in a fully-equipped electrophysiology lab.
• Before using, inspect the Woven or WovenFlexie Diagnostic Electrode Catheters for any defects or physical damage, including electrical insulation on the cables and the catheter shaft that may cause patient and/or user injury if the catheter is used. Do not use defective or damaged devices. Replace damaged device(s) if necessary.
• Contents are supplied STERILE using an EO process and should be used by the ‘‘Use By’’ date on the device package. Do not use the device if past the ‘‘Use By’’ date. Do not use if sterile barrier is damaged as use of non-sterile devices may result in patient injury. If damage is found, call your BSC representative.
• Diagnostic catheter mapping and pacing procedures present the potential for significant x-ray 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 x-ray beam intensity and duration of the fluoroscopic imaging. Catheter mapping and diagnostic pacing procedures 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. Careful consideration must therefore be given for this use of the device in pregnant women and in prepubescent children.
• To ensure correct clinical therapeutic decisions derived from cardiac mapping, the physician must verify results and catheter location using other visualization techniques including but not limited to fluoroscopy, ultrasound and/or pace mapping.
• If a sheath is used, pre-size the catheter to the inner diameter of the sheath prior to insertion to reduce the incidence of catheter entrapment within the sheath requiring removal of the sheath catheter assembly, loss of the insertion site and possibly aborting the procedure.
• Electrical recording or stimulation equipment must be isolated. Care must be taken to ensure that any equipment used in connection with the BSC catheters be type CF, be defibrillation proof, and 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.
• Use only isolated amplifiers, pacing equipment, and ECG equipment or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed IEC 60601-1 electrical safety requirements.
• Stimulation of cardiac tissues caused by pacing stimulus may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns.
• Catheter advancement should be done using electrogram and fluoroscopic guidance to the targeted endocardial site. At no time should the Woven or WovenFlexie Diagnostic Electrode Catheters be advanced or withdrawn when resistance is felt, without determining the cause. Valve damage, lead displacement, vascular and/or cardiac perforation and/or tamponade are risks with any intracardiac catheter.
• Catheter entrapment within the heart or blood vessels is a possible complication of cardiac diagnostic mapping procedures. The potential for catheter entrapment may be increased when the catheter is overtorqued 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.
• Manual bending, excessive curves, kinking or twisting of the Woven or WovenFlexie Diagnostic Electrode Catheters may damage internal wires and components. This damage may affect steering performance and may cause catheter failure and/or patient injury.
• Patients with hemodynamic instability or cardiogenic shock are at increased risk for life- threatening adverse events. Perform mapping and pacing with extreme caution.
• These catheters are not intended to be used for ablation or internal cardioversion. Doing so may result in perforation, arrhythmias, embolism, thrombus and/or patient death.• If used, 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 the catheter with organic solvents such as alcohol or immerse the handle cable connector in fluids. This may result in electrical or mechanical catheter failures. If the catheter is inserted in the vasculature, the exposure of solvents may cause a toxic reaction, inflammation or allergic reaction.
• Do not ablate over the diagnostic electrodes on the Woven or WovenFlexie Diagnostic Electrode Catheters. Contact between the ablation catheter tip and the diagnostic electrode may create or aid in transference of char and/or coagulum and may result in embolism and/or damage to the catheter.
• The use of this device in conjunction with cardiac ablation, as part of the diagnosis and treatment of arrhythmias, may pose an increased risk of adverse events, such as cardiac perforation, tamponade, myocardial infarction, cerebral vascular accident, embolism, and hematoma requiring medical intervention, surgical repair and/or blood transfusion.
• Patients with an implanted Pulse Generator (PG) may experience transient interference from programmed electrical stimulation during a diagnostic electrophysiology study.
• Use caution during a diagnostic electrophysiology study for patients with implanted cardiac leads to prevent entanglement of catheter and lead(s).
• Exercise caution when performing an RF cardiac ablation procedure in patients with implanted Pulse Generator (PG) devices. Induction of arrhythmias and changes in PG function can occur. 
• Ensure that the EGM recorder pacing stimulator is not active when connecting the Woven™ or WovenFlexie™ Diagnostic Electrode Catheters to reduce the risk of initiating an arrhythmia.• This device is for single use only. Reuse, reprocessing and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.
• Use only cables with shrouded pin connections. The use of catheters or cables with unprotected male pin connectors present a risk of electrical hazard. Inadvertent attachment of pin connectors to power supply sockets or connectors could result in electrocution of the patient or operator.

PRECAUTIONS

• Use only sterile saline or water to wipe this catheter.
• Ensure that the cable/catheter connection remains dry throughout the procedure. Avoid submerging the catheter handle in any solution.
  
• Electrophysiology catheters and systems are intended for use only in radiation shielded rooms due to electromagnetic compatibility requirements and other hospital safety guidelines.
• After use, this product may be a potential biohazard. Handle and dispose in accordance with accepted medical practice and applicable local, state, and federal laws.
•  

POTENTIAL ADVERSE EVENTS

The potential adverse events may be related to the diagnostic mapping catheter(s) and procedure, and/or interventional therapeutic device(s) and 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.

• Allergic reaction (including anaphylaxis)
• Angina
• Arrhythmias (new or exacerbation of existing
  arrhythmias)
• Arterial-venous injury/fistula
• Atrial septal defect
• Cardiac perforation
• Cardiac/respiratory arrest
• Catheter entrapment
• Cerebrovascular Accident (CVA)
• Chest discomfort/pain/muscular-skeletal discomfort
• Conduction pathway injury
• Complete heart block (transient/permanent)
• Complications of sedative agents/anesthesia
• Congestive heart failure 
• Diaphragmatic paralysis (hemi)
• Effusion (pericardial/pleural)
• Electric shock/electrocution
• Embolism
  (venous/arterial) (e.g., cerebrovascular accident, myocardial infarction, pulmonary
  embolism, device fragment, air, thrombus, char, coagulum)
• Entrapment/entanglement Esophageal injury
• Exposure to biohazard material
• Fluid volume overload
• Gastrointestinal disturbances/Gastroesophageal Reflux
• Disease (GERD)/gastroparesis
• Hematoma/ecchymosis
• Hemorrhage
• Hemothorax
• Hypertension
• Hypotension
• Infection
• Lead dislodgement
• Myocardial infarction
• Nerve injury/nerve palsy/weakness (phrenic/vagus)
• Pericarditis
• Pleuritis
• Pneumothorax
• Pseudoaneurysm
• Pulmonary/pedal edema
• Pulmonary vein stenosis
• Radiation exposure
• Renal insufficiency/failure
• Skin burns (radiation/defibrillator/cardioverter)
• Tamponade
• Transient Ischemic Attack (TIA)
• Thrombosis/vessel occlusion
• Thrombophlebitis
• Valvular damage
• Visual disturbances
• Vasospasm
• Vasovagal reactions
• Vessel trauma (perforation/dissection/rupture)

91099783 (REV AB)