BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXT DETACHABLE COIL, TETRIS

    MDR report key: 590427 · Received April 6, 2005

    Report

    Report Number
    2029214-2005-00019
    Event Type
    Malfunction
    Date Received
    April 6, 2005
    Date of Event
    March 9, 2005
    Report Date
    April 6, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ANEURYSM RUPTURED DURING THE INSERTION OF THE FIRST TETRIS COIL. THE COIL HAS BEEN WITHDRAWN AND THE EMBOLIZATION HAS BEEN COMPLETED USING GDC COILS. NO PATIENT SEQUELAE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, TETRIS ELECTROLYTICALLY DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. N-3-4-T10-TC 903829

    Patients

    Seq Age Sex Outcome Treatment
    1 *