BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-CELERATOR EXCHANGE GUIDEWIRE

    MDR report key: 502981 · Received December 10, 2003

    Report

    Report Number
    2029214-2003-00048
    Event Type
    Malfunction
    Date Received
    December 10, 2003
    Date of Event
    November 4, 2003
    Report Date
    November 10, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ANEURYSM COILING PROCEDURE, VESSEL ACCESS WAS DIFFICULT, AND THE GUIDEWIRE WAS USED TO PLACE THE MICROCATHETER PRIOR TO STENT PLACEMENT. THE GUIDEWIRE WAS LEFT IN POSITION DURING COILING DUE TO THE ACCESS DIFFICULTY. AS THE CASE PROGRESSED, THE MICROCATHETER WAS REPOSITIONED, AND THE GUIDEWIRE WAS PULLED BACK THROUGH THE STENT. AS THE GUIDEWIRE WAS BEING PULLED BACK, THE GUIDEWIRE SEPARATED. THE DISTAL PORTION OF THE GUIDEWIRE WAS LEFT IN THE PATIENT. THERE WAS NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-CELERATOR EXCHANGE GUIDEWIRE GUIDEWIRE DQX MICRO THERAPEUTICS, INC. 103-0601-300 800334J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 3. GDC EMBOLIC COILS,| 1. NEUROFORM STENT, 2. MICRUS EMBOLIC COILS,| 4. PROWLER 10 MICRO CATHETER.