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ORBITER™ PV

Indications, Safety and Warnings

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

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)

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