BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOSAPH

    MDR report key: 190369 · Received September 29, 1998

    Report

    Report Number
    2951239-1998-00004
    Event Type
    Death
    Date Received
    September 29, 1998
    Date of Event
    August 31, 1998
    Report Date
    September 18, 1998
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PLANNED QUADDRUPLE CORONARY BYPASS SURGERY. STATE OF PT'S VASCULATURE ALLOWED FOR ONLY A DOUBLE BYPASS. THE SAPHENOUS VEIN WAS HARVESTED VIA BALLOON DISSECTION SUCCESSFULLY AND USED FOR BYPASS GRAFT. VEIN WAS TESTED FOR VIABILITY PRIOR TO GRAFT AND FOUND ACCEPTABLE. PT EXPIRED THE NIGHT OF THE SURGERY WHEN THE GRAFT DID NOT HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSAPH BALLOON DISSECTOR AND RETRACTOR GDI GENERAL SURGICAL INNOVATIONS 150B-06 802038

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death