BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXT DETACHABLE COIL, MUTLI-DIAMETER

    MDR report key: 603203 · Received May 12, 2005

    Report

    Report Number
    2029214-2005-00030
    Event Type
    Death
    Date Received
    May 12, 2005
    Date of Event
    April 27, 2005
    Report Date
    May 12, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COIL WAS PLACED IN THE ANEURYSM. IN ORDER TO BE PLACED THE COIL HAD TO BE PUSHED WITH THE MICRO CATHETER SEVERAL TIMES. FINALLY IT DIDN'T MOVE ANY MORE IN THE CATHETER AND PROF TRIED TO REMOVE IT THROUGH THE MICRO CATHETER. THE COIL STRETCHED AND COULD NOT BE REMOVED. WHEN TRYING TO REMOVE IT WITH THE MICRO CATHETER THE COIL TORE OFF AND REMAINED IN THE MEDIAN ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, MUTLI-DIAMETER ELECTROLYTICALLY DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. N-6-20-T10-MD 582296

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death