BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERSPEED HYDROPHILIC GUIDEWIRE

    MDR report key: 532261 · Received March 8, 2004

    Report

    Report Number
    2029214-2004-00011
    Event Type
    Malfunction
    Date Received
    March 8, 2004
    Report Date
    March 8, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE GUIDEWIRE SEPARATED IN THE DISTAL SEGMENT DURING OVER-THE-WIRE NAVIGATION WITH A VASCO - 18 CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERSPEED HYDROPHILIC GUIDEWIRE GUIDEWIRE DQX MICRO THERAPEUTICS, INC. 103-0602-200 743044J

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R