SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Additional Manufacturer Narrative

A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED CATHETER. THE REPORTED EVENT OF "PACING CATHETER DID NOT PACE AT ALL" WAS CONFIRMED. CONTINUITY TESTING CONFIRMED A FULL OPEN CONDITION OF THE PROXIMAL AND DISTAL CIRCUIT. CUT DOWN OF THE CATHETER BODY WAS PERFORMED TO EXPOSE THE PACING LEADWIRES. PROXIMAL AND DISTAL LEADWIRES WERE FOUND TO BE BROKEN AT APPROXIMATELY 2.5 CM PROXIMAL OF DISTAL TIP. NO VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY, BALLOON, OR WINDINGS. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND REMAINED INFLATED FOR 5 MIN WITHOUT LEAKAGE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE PRODUCT PASSED ALL MANUFACTURING INSPECTIONS WITHOUT NONCONFORMANCES IDENTIFIED ASSOCIATED TO THE REPORTED MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/ DESIGN DEFECT. AS PER THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH A DELAMINATION INSPECTION OF THE NICKEL MAGNET BIFILAR AND WIRE INSERTION INTO THE CATHETER TUBE. A FINAL CONTINUITY TEST IS ALSO PERFORMED ON THE ELECTRODES. THE INSTRUCTIONS FOR USE (IFU) 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.

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

AS REPORTED, RIGHT AFTER INSERTION IN PATIENT, A SWAN-GANZ PACING CATHETER COULD NOT PACE. ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY.