BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1082358 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08193
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 2, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. INFLATION LUMEN LEAKAGE OBSERVED THROUGH A SLIT ON THE CATHETER BODY. 0.07" IN LENGTH, AT THE 12.6 CM AREA (DISTAL OF THE THERMAL FILAMENT). NO VISIBLE DAMAGE TO BALLOON LATEX.

    Description of Event or Problem · 1

    REPORTEDLY, THE BALLOON WAS DEFECTIVE AND THE BALLOON CANNOT BE INFLATED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 746HF8 58327711

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other