SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Description of Event or Problem

AS REPORTED, DURING USE IN A PATIENT UNDERGOING A TRANSCATHETER AORTIC VALVE IMPLANTATION, A SWAN-GANZ PACING CATHETER DID NOT PACE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY.

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.

Additional Manufacturer Narrative

IT WAS PREVIOUSLY REPORTED THAT THE LOT NUMBER WAS NOT AVAILABLE. THE LOT NUMBER WAS IDENTIFIED WITH THE RETURNED PRODUCT. LOT NUMBER IS 65582376. A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED BIPOLAR PACING CATHETER. THE REPORTED EVENT OF PACING ISSUE WAS CONFIRMED. CONTINUITY TESTING CONFIRMED A FULL OPEN CONDITION OF THE PROXIMAL CIRCUIT. THE DISTAL CIRCUIT WAS FOUND TO BE CONTINUOUS. A CUT DOWN OF THE CATHETER BODY WAS PERFORMED JUST PROXIMAL OF THE PROXIMAL ELECTRODE TO EXPOSE THE PACING LEADWIRES. IT WAS OBSERVED THAT THE PROXIMAL LEADWIRE WAS BROKEN AT 3 CM PROXIMAL FROM CATHETER TIP. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND REMAINED INFLATED FOR MORE THAN 5 MIN. WITHOUT LEAKAGE. NO VISIBLE DAMAGE OR DEFECT WAS OBSERVED FROM THE BALLOON, WINDINGS, CATHETER BODY AND RETURNED SYRINGE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION AND PREVIOUS EVALUATIONS, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/ DESIGN DEFECT. 100% OF THE UNITS THE UNITS GO THROUGH A DELAMINATION INSPECTION OF THE BIFILAR NICKEL MAGNET WIRE, A CONTINUITY TEST IS PERFORMED FOR THE DISTAL AND PROXIMAL ELECTRODES, AND FOR THE WIRE INSERTION INTO THE CATHETER TUBE. A FINAL CONTINUITY TEST IS PERFORMED TO THE ELECTRODES. THE INSTRUCTIONS FOR USE STATES PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: THIS CATHETER REQUIRES SPECIAL TECHNIQUES FOR INSERTION AND REMOVAL. ELECTRODE DISLODGEMENT MAY RESULT FROM PULLING THE CATHETER OUT THROUGH THE PERCUTANEOUS SHEATH. AVOID FORCEFUL WIPING OR STRETCHING OF THE CATHETER DURING TESTING AND CLEANING AS NOT TO BREAK THE ELECTRODE WIRE CIRCUITRY. SINCE PROPER FUNCTIONING OF THE PACING CATHETER DEPENDS ON THE ELECTRICAL CONTINUITY OF ITS ELECTRODES AND INTERNAL WIRES, CARE SHOULD BE EXERCISED WHEN HANDLING THE CATHETER.