SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

Additional Manufacturer Narrative

THE DEVICE WAS DISCARDED, THEREFORE, A PRODUCT EVALUATION COULD NOT BE COMPLETED. WITHOUT THE RETURN OF THE DEVICE, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS A LOT NUMBER WAS NOT PROVIDED. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. 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 PART OF THIS MONTHLY REVIEW.

Description of Event or Problem

AS REPORTED DURING USE IN A PATIENT THIS SWAN GANZ PACING CATHETER DID NOT PACE AT ALL. WHEN THIS CATHETER WAS REPLACED THE ISSUE WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED BY THE HOSPITAL.