BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARD'S LIFESCIENCE LLC

    MDR report key: 406201 · Received July 19, 2002

    Report

    Report Number
    406201
    Event Type
    Injury
    Date Received
    July 19, 2002
    Date of Event
    June 3, 2002
    Report Date
    June 4, 2002
    Manufacturer
    EDWARDS'S LIFESCIENCE LLC
    Product Code
    DXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THROMBECTOMY CATHETER RUPTURES (BALLOON) IN VEIN DURING PROCEDURE DAMAGING VEIN TO EXTENT IT HAD TO BE LIGATED AND A-V GRAFT CLOSED. LVE UNUSABLE FOR FUTURE DIALYSIS ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARD'S LIFESCIENCE LLC ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS'S LIFESCIENCE LLC 12080YF 512DC982/512BC890

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention| S