TRANSLUMINAL BIPOLAR PACING PROBE

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 REVIEW WAS NOT YET 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 JUST RIGHT AFTER INSERTION IN A PATIENT THIS SWAN GANZ PACING CATHETER DID NOT PACE AT ALL. WHEN THIS CATHETER WAS REPLACED THE PROBLEM WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ONE SWAN GANZ PACING CATHETER WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF PACING ISSUE WAS CONFIRMED. CONTINUITY TESTING CONFIRMED A FULL OPEN CONDITION OF THE DISTAL CIRCUIT. THE PROXIMAL 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 LEAD WIRES. IT WAS OBSERVED THAT THE DISTAL LEAD WIRE WAS BROKEN NEAR THE DISTAL ELECTRODE. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND REMAINED INFLATED FOR MORE THAN 5 MINUTES WITHOUT LEAKAGE. NO VISIBLE DAMAGE OR DEFECT WAS OBSERVED FROM THE BALLOON, WINDINGS, CATHETER BODY AND RETURNED SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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. 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. THEREFORE A ROOT CAUSE COULD NOT BE ESTABLISHED.