BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)

    MDR report key: 6183224 · Received December 16, 2016

    Report

    Report Number
    2015691-2016-03770
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K822723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIPOLAR PACING CATHETER WITH ATTACHED MONOJECT 1.3 CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. CONTINUITY TESTING CONFIRMED FULL OPEN CONDITIONS OF THE PROXIMAL CIRCUIT AND THE DISTAL CIRCUIT. A CUT DOWN OF THE CATHETER BODY WAS PERFORMED JUST PROXIMAL OF THE PROXIMAL ELECTRODE TO EXPOSE THE PACING LEADWIRES. THE PROXIMAL AND DISTAL LEADWIRES WERE FOUND TO BE BROKEN AROUND THE SOLDER JOINTS. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO VISIBLE DAMAGE OR ABNORMALITY TO THE CATHETER BODY, BALLOON, WINDINGS OR RETURNED SYRINGE WAS OBSERVED. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 1.3 CC AIR BY HOLDING THE BALLOON UNDER WATER. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION AND WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. CUSTOMER REPORT OF PACING ISSUE WAS CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THIS EVENT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS . SWAN-GANZ PACING THERMODILUTION (TD) CATHETERS SERVE AS DIAGNOSTIC AND THERAPEUTIC TOOLS IN THE MANAGEMENT OF CRITICALLY ILL PATIENTS. THERE ARE MULTIPLE FAILURE MODES THAT MAY REQUIRE THE EXCHANGE OF A PACING CATHETER. 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. STRETCHING, KINKING, OR FORCEFUL WIPING OF THE CATHETER MAY RESULT IN DAMAGE. AFTER STABLE PACING HAS BEEN CONFIRMED, THE PROXIMAL END OF THE CATHETER SHOULD BE SECURED TO THE INSERTION SITE TO PREVENT UNDUE MOVEMENT THAT COULD RESULT IN TIP DISLODGMENT AND LOSS OF CAPTURE, OR CATHETER MIGRATION. CARE SHOULD BE TAKEN NOT TO KINK THE CATHETER BODY WHEN SECURING IT. IN THIS COMPLAINT, IT COULD NOT BE DETERMINED IF PROCEDURAL FACTORS OR DEVICE HANDLING MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO PACE FROM THE BEGINNING OF USE. THE CATHETER WAS REPLACED AND THE PROBLEM WAS SOLVED. FURTHER DETAIL COULD NOT BE OBTAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT DEMOGRAPHIC INFORMATION REQUESTED BUT UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834256 SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA) PACING CATHETER DYG EDWARDS LIFESCIENCES, PR D97120F5 60347083

    Patients

    Seq Age Sex Outcome Treatment
    1