BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER "S" TIP CATHETER FOR FEMORAL INSERT

    MDR report key: 1082664 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08124
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K810124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CUSTOMER WAS REMOVING THE CATHETER, THE CLINICIAN FELT SOMETHING WAS WRONG AT THE SHEATH AREA. CUSTOMER REMOVED THE CATHETER WITH THE SHEATH BUT THE BALLOON LATEX WAS DETACHED FROM THE CATHETER. CUSTOMER TRIED THE COMPUTED TOMOGRAPHY ANGIOGRAPHY, BUT THE MISSING LATEX WAS NOT FOUND. EVENT OCCURRED DURING A CARDIAC CATHERIZATION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER "S" TIP CATHETER FOR FEMORAL INSERT THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 151F7 58408977

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other