BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE TENSION SAFE COIL

    MDR report key: 510803 · Received February 1, 2004

    Report

    Report Number
    2029214-2004-00003
    Event Type
    Injury
    Date Received
    February 1, 2004
    Date of Event
    October 1, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COIL WAS DIFFICULT TO PUSH INTO THE MICRO CATHETER. COIL BECAME DAMAGED AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE TENSION SAFE COIL DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. E-3-8-T10-TS 75141

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention