TRANSLUMINAL BIPOLAR PACING PROBE

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. 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

AS REPORTED, DURING USE IN PATIENT, THE SWAN-GANZ PACING CATHETERS DID NOT SENSE NOR PACE. THE FIRST CATHETER WAS ABLE TO SENSE AND PACE FOR PART OF THE PROCEDURE BUT THEN STOPPED WORKING. THE CATHETER USED TO REPLACE THE FIRST CATHETER DID NOT SENSE OR PACE FROM THE BEGINNING OF USE. THE PROBLEM WAS SOLVED BY REPLACING THE SECOND CATHETER WITH A NEW ONE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

ONE BIPOLAR CATHETER WITH ATTACHED MONOJECT LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF PACING DIFFICULTY WAS CONFIRMED. CONTINUITY TESTING CONFIRMED A FULL OPEN CONDITION OF THE DISTAL CIRCUIT. CUT DOWN OF THE CATHETER BODY WAS PERFORMED TO EXPOSE THE PACING LEAD WIRES. DISTAL LEADWIRE WAS FOUND TO BE BROKEN/DETACHED AT THE TIP. PROXIMAL CIRCUIT WAS CONTINUOUS. NO VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY, BALLOON AND RETURNED SYRINGE. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE IFU PROVIDES INSTRUCTIONS ON CATHETER MANIPULATION TO AVOID ANY DAMAGE TO THE ELECTRICAL CIRCUIT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/ DESIGN DEFECT. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH AN ELECTRICAL CONTINUITY INSPECTION FOR PROXIMAL AND DISTAL ELECTRODES.