TRANSLUMINAL BIPOLAR PACING PROBE

Additional Manufacturer Narrative

ONE PACING CATHETER WITH MONOJECT LIMITED VOLUME SYRINGE 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, WINDINGS OR RETURNED SYRINGE. 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. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD BE CONFIRMED AS NO DEFECT WAS FOUND. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION PROCESS. THE INSTRUCTIONS FOR USE ALSO PROVIDES INSTRUCTIONS ON CATHETER MANIPULATION TO AVOID ANY DAMAGE TO THE ELECTRICAL CIRCUIT.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. 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 SWAN-GANZ PACING CATHETER IN A TAVI PROCEDURE, THE CATHETER DID NOT PACE FROM THE BEGINNING OF USE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE BRAND/SIZE OF THE USED INTRODUCER WAS TERUMO, 5FR. THERE WAS NO ALLEGATION OF PATIENT INJURY.