BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 4182471 · Received October 17, 2014

    Report

    Report Number
    2015691-2014-02452
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K813521
    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 1.3CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. CONTINUITY TESTING CONFIRMED A SHORT CONDITION IN THE Y-ADAPTOR BETWEEN THE PROXIMAL AND DISTAL LEADWIRES. NO OPEN OR SHORT CONDITION WAS OBSERVED IN THE LEADWIRES DISTAL OF THE Y-ADAPTOR AND THE ELECTRODES. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND DID NOT LEAK. NO VISIBLE DAMAGE TO THE CATHETER BODY, BALLOON, WINDINGS, OR RETURNED SYRINGE WAS OBSERVED. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION AND WITH THE UNAIDED EYES. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660400 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5

    Patients

    Seq Age Sex Outcome Treatment
    1