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

IT WAS REPORTED THAT DURING USE OF THE PACING CATHETER IT DID NOT PACE AT ALL WHEN SET TO 8 VOLTS FOR BACKUP. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

ONE PACING CATHETER WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF PACING DIFFICULTIES WAS UNABLE 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION. THE INSTRUCTIONS FOR USE ALSO PROVIDES INSTRUCTIONS ON CATHETER MANIPULATION TO AVOID ANY DAMAGE TO THE ELECTRICAL CIRCUIT.