SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR RETURN 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. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED ASSOCIATED TO THE REPORTED MALFUNCTION. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 AFTER INSERTION IN PATIENT THIS SWAN GANZ PACING CATHETER DID NOT PACE AT ALL. WHEN THIS CATHETER WAS REPLACED THE PROBLEM WAS SOLVED. THE CATHETER WAS TO BE USED FOR EMERGENCY. THE SIZE OF THE SHEATH INTRODUCER USED WITH THIS CATHETER WAS 5 FR. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED BY THE HOSPITAL.