SWAN-GANZ BIPOLAR PACING

Additional Manufacturer Narrative

CUSTOMER REPORT OF DID NOT PACE 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 1.5 CM PROXIMAL FROM CATHETER TIP. 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, AND CATHETER BODY. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AS PER MANUFACTURING PROCESS, THERE IS VERIFICATION OF THE NICKEL MAGNET BIFILAR FOR DELAMINATION AND THE INSERTION OF THE WIRE INTO THE CATHETER TUBE AS PER PROCEDURE. ALSO, THE PROCEDURE INCLUDES INSTRUCTIONS TO PERFORM THE SOLDERING OF THE ELECTRODES. A FINAL CONTINUITY TEST IS PERFORMED TO THE ELECTRODES AS PER THE PROCEDURE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE INSTRUCTIONS FOR USE PROVIDES INSTRUCTIONS ON CATHETER MANIPULATION TO AVOID ANY DAMAGE TO THE ELECTRICAL CIRCUIT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT AS THE CUSTOMER REPORTED IT WAS DURING PROCEDURE. THEREFORE, A ROOT CAUSE COULD NOT BE ESTABLISHED.

Description of Event or Problem

AS REPORTED DURING USE IN A PATIENT THIS SWAN GANZ PACING CATHETER DID NOT PACE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE BRAND/SIZE OF THE USED INTRODUCER IS UNCLEAR. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

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 WAS NOT COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. 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.