BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3942302 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01614
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    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 WITH ORIGINAL OPENED PACKAGING BOX. NO INTRODUCER WAS RETURNED. CONTINUITY TESTING CONFIRMED A FULL OPEN CONDITION OF THE PROXIMAL CIRCUIT IN THE Y-ADAPTOR. NO OPEN OR SHORT CONDITIONS WERE OBSERVED IN THE LEAD WIRES BETWEEN THE DISTAL SIDE OF THE Y-ADAPTOR AND THE ELECTRODES. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO VISIBLE DAMAGE TO THE BALLOON, BALLOON WINDINGS, OR CATHETER BODY 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 10X MAGNIFICATION AND WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT OF PACING DIFFICULTY WAS CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE. ANOTHER CATHETER WITH DIFFERENT LOT NUMBER WAS USED AND THE PROBLEM WAS SOLVED." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419995 SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA) PACING CATHETER DYG EDWARDS LIFESCIENCES, PR D97120F5 59676363

    Patients

    Seq Age Sex Outcome Treatment
    1