BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILVERSPEED 14 GUIDEWIRE

    MDR report key: 511254 · Received February 12, 2004

    Report

    Report Number
    2029214-2004-00007
    Event Type
    Death
    Date Received
    February 12, 2004
    Date of Event
    November 1, 2003
    Report Date
    February 12, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH A GIANT ANEURYSM AT THE RIGHT ICA, CLOSE TO THE OPHTHALMIC ARTERY. THE DOCTOR HAD DIFFICULTY PLACING THE BALLOON ACROSS THE NECK OF THE ANEURYSM. THE ENTIRE PROCEDURE TOOK 7 HOURS. THE ANEURYSM WAS 100% EMBOLIZED WITH THE ICA PATENT AND NO CROSSING ARTERIES OCCLUDED. THE PT RECOVERED TO FULL CONSCIOUSNESS AFTER THE OPERATION, BUT CONDITION WORSENED 1/2 HOUR LATER. CT SCAN REVEALED A LARGE HEMATOMA IN RIGHT BASILAR AREA. THE DOCTOR COULD NOT DETERMINE WHAT CAUSED THE HEMORRHAGE, PERFORATION BY GUIDEWIRE, OR HEPARIN OVERDOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERSPEED 14 GUIDEWIRE GUIDEWIRE DQX MICRO THERAPEUTICS, INC. 103-0602-200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death