SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

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. THE DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED.

Description of Event or Problem

AS REPORTED, DURING USE IN PATIENT, A SWAN-GANZ PACING CATHETER DID NOT PACE AT THE BEGINNING OF THE PROCEDURE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE BRAND/SIZE OF THE USED INTRODUCER IS UNCLEAR. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

ONE CATHETER WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF "UNABLE TO PACE" 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 UNDER THE BALLOON. 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. BASED ON THE AVAILABLE INFORMATION, 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. 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.