BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOFLO VASCULAR GRAFT

    MDR report key: 1983609 · Received February 2, 2011

    Report

    Report Number
    2020394-2011-00017
    Event Type
    Death
    Date Received
    February 2, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DYF
    PMA / PMN Number
    K004012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A EPTFE THINWALL VASCULAR GRAFT WAS IMPLANTED IN THE AXILLO-FEMORAL POSITION. SEVERAL DAYS LATER, THE AXILLARY ANASTOMOSIS DISRUPTED AND THE PT DIED. ADDITIONAL INFO IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOFLO VASCULAR GRAFT DYF BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death