SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Description of Event or Problem

IT WAS REPORTED THAT, DURING USE, A SWAN-GANZ PACING CATHETER DID NOT PACE AFTER POSITIONING THE CATHETER. THE CATHETER WAS REPLACED AND THE PROBLEM WAS SOLVED. THE SIZE OF THE SHEATH INTRODUCER USED IN THE CASE IS UNKNOWN. 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

A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED CATHETER. THE REPORTED EVENT OF PACING DIFFICULTIES WAS CONFIRMED. CONTINUITY TESTING CONFIRMED A FULL OPEN CONDITION OF THE PROXIMAL CIRCUIT. CUT DOWN OF THE CATHETER BODY WAS PERFORMED TO EXPOSE THE PACING LEAD WIRES. PROXIMAL LEADWIRE WAS FOUND TO BE BROKEN AT APPROXIMATELY 5 CM PROXIMAL OF DISTAL TIP. DISTAL CIRCUIT WAS CONTINUOUS. NO VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY OR BALLOON. 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 COULD NOT BE PERFORMED SINCE LOT NUMBER WAS NOT REPORTED. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/ DESIGN DEFECT. THE AFFECTED FINAL WORK ORDER DOCUMENTATION AND MANUFACTURING WERE VERIFIED, AND NO DEFICIENCIES WERE FOUND. 100% OF 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 (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.