TRANSLUMINAL BIPOLAR PACING PROBE

Additional Manufacturer Narrative

ONE PACING CATHETER WITH ATTACHED MONOJECT LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF INABILITY TO PACE WAS NOT ABLE TO BE CONFIRMED. NO VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY, BALLOON OR WINDINGS. CONTINUITY TESTING WAS PERFORMED ON THE DISTAL AND PROXIMAL CIRCUITS AND THERE WERE NO OPEN, INTERMITTENT, OR SHORT CONDITIONS OBSERVED. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND THE BALLOON 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. SINCE THE COMPLAINT AFFECTED UNIT WAS RETURNED FOR EVALUATION AND NO DEFECT WAS FOUND A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD NOT BE CONFIRMED. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED, AS THE LOT NUMBER WAS NOT PROVIDED.

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

IT WAS REPORTED THAT AFTER INSERTING THE PACING CATHETER INTO PATIENT, THE CATHETER DID NOT PACE WHEN CONNECTED TO THE EXTERNAL PACEMAKER. WHEN THE CATHETER WAS REPLACED, THE PROBLEM WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY.