BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE TENSION SAFE DETACHABLE COIL

    MDR report key: 538074 · Received August 6, 2004

    Report

    Report Number
    2029214-2004-00044
    Event Type
    Injury
    Date Received
    August 6, 2004
    Date of Event
    July 8, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING DIFFICULT PLACEMENT AND REPOSITIONING OF THREE COILS, PT EXPERIENCED VASOSPASM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE TENSION SAFE DETACHABLE COIL DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. E-2-2-T10-TS 626063

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening