BEUDAMED
    FDA Adverse Event Death Summary report: N

    X-CELERATOR EXCHANGE GUIDEWIRE

    MDR report key: 599154 · Received May 5, 2005

    Report

    Report Number
    2029214-2005-00028
    Event Type
    Death
    Date Received
    May 5, 2005
    Date of Event
    March 14, 2005
    Report Date
    May 5, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT IN FOR ELECTIVE ANEURYSM COILING (VERY WIDE-NECK BASILAR TIP) AND GOAL WAS TO PLACE 2 NEUROFORM 2 STENTS (Y STENT TECHNIQUE) BEFORE COILING. PHYSICIAN PLACED ECHELON 14 MICRO CATHETER INTO RIGHT PCA WITH ASSISTANCE FROM SYNCHRO 14 GUIDEWIRE. SYNCHRO 14 WAS REMOVED AND PHYSICIAN ATTEMPTED TO PLACE X-CELERATOR 14 EXCHANGE WIRE OUT THE MICRO CATHETER INTO THE DISTAL PCA FOR SUPPORT IN STENT PLACEMENT. PHYSICIAN THOUGHT WIRE WAS IN PCA BUT ACTUALLY PLACED INTO TINY FEEDER VESSEL OFF THE PCA AND RUPTURED THE VESSEL. LARGE AMOUNT OF CONTRAST EXTRAVASATION WAS EVIDENT, PHYSICIAN INJECTED NBCA INTO THE VESSEL AND WAS ABLE TO STOP BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-CELERATOR EXCHANGE GUIDEWIRE GUIDEWIRE DQX MICRO THERAPEUTICS, INC. 103-0602-300 960718

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death