BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE MICROCOIL

    MDR report key: 1183223 · Received October 2, 2008

    Report

    Report Number
    1183223
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 2, 2008
    Manufacturer
    MICRUS ENDOVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO DEFECTIVE COILS; ONE COIL FAILED TO RE-SHEATH AND THE OTHER COIL FAILED TO LOAD. NEITHER COIL WAS IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUSPHERE MICROCOIL COIL, EMBOLIZATION HCG MICRUS ENDOVASCULAR * F44385
    2 MICRUSPHERE MICROCOIL COIL, EMBOLIZATION HCG MICRUS ENDOVASCULAR * F44701

    Patients

    Seq Age Sex Outcome Treatment
    1 *