BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSEND .014" FLOPPY 300 CM

    MDR report key: 664251 · Received January 13, 2006

    Report

    Report Number
    6000078-2005-00262
    Event Type
    Death
    Date Received
    January 13, 2006
    Date of Event
    December 5, 2005
    Report Date
    January 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORP WAS MADE AWARE THAT DURING A MIDDLE CEREBRAL ARTERY ANEURYSM PROCEDURE, PRIOR TO STENT DEPLOYMENT, THE SUBJECT DEVICE PERFORATED THE VESSEL WALL. THE PROCEDURE WAS UNSUCCESSFUL AND THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND .014" FLOPPY 300 CM GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION * 7822324

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death