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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/INDICATIONS FOR USE

Radia Bidirectional Steerable 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.

WARNINGS

  • This device should be used only by physicians thoroughly trained in the techniques of intracardiac electrophysiology studies and temporary pacing.
  • The risks of using electrophysiology catheters include those risks related to heart catheterization such as thromboembolism, perforation, tamponade, and infection. The induction of an unintended arrhythmia is a known complication.
  • 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.
  • Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
  • Catheter advancement and adjustments should be done under fluoroscopic guidance.

PRECAUTIONS

  • Use only sterile saline or water to wipe this catheter.
  • Avoid submerging the catheter handle in any solution.
  • For catheters equipped with a cable connector, use with the appropriate Boston Scientific cable.
  • Excessive bending, torquing or kinking of the electrode catheter may cause damage to the catheter, including damage to the internal wires.

91063815 (Rev AA)

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