BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2033499 · Received March 24, 2011

    Report

    Report Number
    2954740-2011-00013
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    Adverse Event
    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 RECORDS 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

    DESPITE SEVERAL ATTEMPTS TO DETACH THE COIL, THE COIL FAILED TO DETACH. DURING RETRIEVAL, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. PART OF THE COIL WAS PUSHED BACK IN THE ANEURYSM. HOWEVER, ONE LOOP (ABOUT 1/4 IN LENGTH) MIGRATED OUT OF THE MAIN VESSEL. INITIAL AND F/U REPORTS CONFIRMED THAT NO ADDITIONAL INTERVENTION WAS PERFORMED TO RETRIEVE THE COIL AND NO ADDITIONAL MEDICATION WAS PRESCRIBED. THE PT WAS DOING FINE AND NO SPECIFIC DETERIORATION WAS NOTED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION PC4100517-30 F61453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention