TRANSLUMINAL BIPOLAR PACING PROBE

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ PACING CATHETER IT PROVIDED NOISE, A ZIGZAG PACING WAVEFORM, AND DID NOT PACE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY.