ORBITER™ PV

INTENDED USE

ORBITER PV Mapping Diagnostic Catheter is intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

CONTRAINDICATIONS

• The catheter should not be used in conditions where manipulation of the catheter would be unsafe (e.g. intracardiac mural thrombus).
• The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
• The retrograde transaortic approach is contraindicated due to the risk of entrapping the tip in the left ventricle.

WARNINGS

• This device should be used only by physicians thoroughly trained in the techniques of intracardiac electrophysiology studies, catheter ablation, and temporary pacing.
• Reuse 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.
• The risks of using electrophysiology catheters include those risks related to heart catheterization such as thromboembolism, perforation, tamponade, pneumothorax, and infection. The induction of an unintended arrhythmia is a known complication of electrophysiologic procedures.
• Do not immerse the proximal handle or cable connector in fluids; electrical performance could be affected.
• To place the ORBITER PV catheter, torque (or rotate) shaft in a clockwise motion only.

PRECAUTIONS

• Do not use excessive force to advance or withdraw the catheter when resistance is encountered because tissue damage or perforation could occur.
• All catheter adjustments should be done under fluoroscopic guidance.
• Use only sterile saline or water to wipe this catheter.
• For catheters equipped with a cable connector, use with the appropriate Boston Scientific cable.
• Excessive bending or kinking of the electrode catheter may cause damage to the catheter, including internal wires.
• Avoid fluid penetration into handle. Do not submerge the handle in any solution.
• Ensure that the loop is fully expanded and the catheter tip has been returned to the neutral position prior to removal from the patient.
• To avoid potential damage to anatomical structures, do not attempt to pull the catheter, or withdraw it with the loop in a contracted state. The loop should be fully expanded prior to removal from the patient.

91063813 (REV AA)