SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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

AS REPORTED DURING USE IN A PATIENT THIS SWAN GANZ PACING CATHETER DID NOT PACE. THE SIZE OF SHEATH INTRODUCER USED WITH THIS CATHETER WAS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED BY THE HOSPITAL.