BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2191259 · Received July 19, 2011

    Report

    Report Number
    2954740-2011-00045
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K091504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE MFG REPORTS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY RELEVANT DISCREPANCIES, DESIGN OR QUALITY CONCERNS. A SEARCH OF OUR FIELD SURVEILLANCE DATABASE YIELDED NO OTHER COMPLAINTS OF THIS TYPE WITH THIS LOT.

    Description of Event or Problem · 1

    AFTER THE COIL WAS DEPLOYED IN THE ANEURYSM, ATTEMPTS WERE MADE TO DETACH THE COIL BY PRESSING THE "DETACH" BUTTON OF THE DETACHMENT CONTROL BOX (DCB) SEVERAL TIMES UNSUCCESSFULLY. AS THE COIL WAS BEING WITHDRAWN, THE COIL DETACHED UNINTENTIONALLY IN THE MICROCATHETER. THE ENTIRE SYSTEM WAS SAFELY WITHDRAWN WITH NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION G12058

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening