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
Bard's Fixed Curve Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
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 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.
- Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
- If using an open lumen catheter remove any guidewire/stylette prior to electrical stimulation.
- Excessive bending, torquing or kinking of the electrode catheter may cause damage to the catheter, including damage to the internal wires.
- Use only sterile saline or water to wipe this catheter.