BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1051932 · Received May 20, 2008

    Report

    Report Number
    6000002-2008-07265
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 17, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K924452
    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. BALLOON LUMEN LEAKAGE OBSERVED THROUGH A SLIT OF THE CATHETER BODY, 0.06" IN LENGTH, AT THE 12.5 CM AREA (DISTAL OF THE THERMAL FILAMENT). NO VISIBLE DAMAGE TO BALLOON LATEX. A CAPA IS IN PROCESS FOR SLIT IN CATHETER BODY RELATED TO BALLOON INFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE AND THE BALLOON COULD NOT MAINTAIN INFLATION. NO PATIENT 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 744HF75 58430878

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other