SWAN-GANZ BIPOLAR PACING CATHETER

Additional Manufacturer Narrative

ONE SWAN GANZ CATHETER WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF "DID NOT PACE" WAS UNABLE TO BE CONFIRMED. NO VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY, SYRINGE, 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. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT ANY NONCONFORMANCE. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION PROCESS. THE JAPANESE IFU INDICATES INSTRUCTIONS TO HANDLE THE CATHETER WITH CAUTION FOR PROPER FUNCTIONING OF THE PACING CATHETER. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT AS NO DEFECT WAS FOUND. THEREFORE, A ROOT CAUSE COULD NOT BE ESTABLISHED.

Additional Manufacturer Narrative

AS REPORTED DURING A TAVI PROCEDURE THIS SWAN-GANZ PACING CATHETER DID NOT PACE FROM THE BEGINNING OF USE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PATIENT HAD NO CARDIAC CONDUCTION DEFECT. THE BRAND/SIZE OF THE USED INTRODUCER IS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT BEEN 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 A TAVI PROCEDURE THIS SWAN-GANZ PACING CATHETER DID NOT PACE FROM THE BEGINNING OF USE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PATIENT HAD NO CARDIAC CONDUCTION DEFECT. THE BRAND/SIZE OF THE USED INTRODUCER IS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.