BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN GANZ THERMODILUTION CATHETER

    MDR report key: 842202 · Received April 13, 2007

    Report

    Report Number
    6000002-2007-00245
    Event Type
    Death
    Date Received
    April 13, 2007
    Date of Event
    February 22, 2007
    Report Date
    March 27, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: OUR EXAMINATION OF THE CATHETER FOUND THAT THE BALLOON WAS RUPTURED 2/3 AROUND THE CIRCUMFERENCE OF THE CENTRAL AREA OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN GANZ THERMODILUTION CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES 139HF75P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death