BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 1813525 · Received August 24, 2010

    Report

    Report Number
    2015691-2010-13944
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    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

    CUSTOMER REPORT WAS CONFIRMED. CATHETER WAS FOUND TO HAVE A SHORT CONDITION BETWEEN THE PROXIMAL AND DISTAL ELECTRODES AT THE Y-ADAPTER AREA. BALLOON INFLATED CLEARLY AND CONCENTRICALLY, AND LEAKAGE WAS NOT OBSERVED. THERE WAS NO VISIBLE DAMAGE OBSERVED TO THE CATHETER BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A PACING FAILURE OCCURRED DURING USE." 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 LDF EDWARDS LIFESCIENCES, PR PE074F5 58840428

    Patients

    Seq Age Sex Outcome Treatment
    1