BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 1243199 · Received November 10, 2008

    Report

    Report Number
    6000002-2008-09229
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. CONTINUITY TESTING CONFIRMED THERE TO BE A SHORT CONDITION BETWEEN THE DISTAL AND PROXIMAL ELECTRODES. FURTHER TESTING CONFIRMED THE SHORT CONDITION WAS INSIDE THE Y FITTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO PACE FROM THE BEGINNING. ANOTHER DEVICE WAS USED AND THE PROBLEM WAS SOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER DYG EDWARDS LIFESCIENCES, PR PE074F5 58507027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other