BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENTRY

    MDR report key: 617795 · Received June 28, 2005

    Report

    Report Number
    617795
    Event Type
    Death
    Date Received
    June 28, 2005
    Date of Event
    March 17, 2005
    Report Date
    March 25, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GBA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTS WITH NEW ONSET CVA MCA INFARCT - TPA ATTEMPTED/ONSUCCESSFUL - ATTEMPTED BALLOON PROCEDURE. UPON PLACING THE BALLOON IN THE VESSEL, ATTEMPTED TO INFLATE - COULDN'T SEE BALLOON INFLATE. THEREFORE, INJECTED A BIT MORE CONTRAST DYE IN AN ATTEMPT TO VISUALIZE; CATHETER BACKED OUT, AND A PUFF OF CONTRAST WAS NOTED AND IT WAS VERIFIED THAT THE BALLOON HAD RUPTURED. VESSEL RUPTURED AND A HEMORRHAGE TO INCLUDE THE SUBARACHNOID SPACE DEVELOPED; BRAIN HERNIATED, VENTILATED, FM NADE A NDR AND CONDUCTED A TERMIRAL WEAN. 3/17 - CT HEADERBRAIN WITHOUT CONTRAST AND POSITIVE FOR A RIGHT GREATER THAN LEFT SYLIVAN FISSURE ACUTE FROM RIGHT INTO THE SUPRASELLAR OSTERN. REGIONAL MASS EFFECTS WITHOUT BRAIN HERNIATION. DIFFUSE SUBARACHROID AND INTRAVENTRIEVIER EXTENSION OF RADIOGRAPHIC CONTRAST PRESUNABLY ADMIXED WITH HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTRY BALLOON GBA BOSTON SCIENTIFIC * 050107 B3

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death