BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2152253 · Received June 23, 2011

    Report

    Report Number
    2954740-2011-00030
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORP.
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PRODUCT HAS NOT BEEN RECEIVED BY OUR FACILITY. WE WILL FILE A FOLLOW UP REPORT AS SOON AS THE PRODUCT IS RECEIVED AND FINAL ANALYSIS HAS BEEN CONDUCTED.

    Description of Event or Problem · 1

    A PT WAS BEING TREATED FOR A 4.5 X 3.5MM ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (ACOM). UPON PLACEMENT OF THE COIL INTO THE ANEURYSM, A SMALL LOOP WAS OBSERVED. AS THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL, THE MICROCATHETER WOULD NOT ADVANCE BACK IN. IT WAS FOUND OUT THAT THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. A MICROSNARE WAS USED TO SUCCESSFULLY RETRIEVE THE COIL. ADDITIONAL INFORMATION RECEIVED FROM THE REP ON (B)(6) 2011 STATED THAT THERE WAS NO ATTEMPT TO DETACH THE COIL, THE PROCEDURE WAS COMPLETED AND THE PT WAS DOING WELL POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORP. F65962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention