BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2120192 · Received June 6, 2011

    Report

    Report Number
    2954740-2011-00028
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE MANUFACTURING 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

    PER RECEIVED REPORT: INTERNAL CAROTID ARTERY (ICA) ANEURYSM WAS BEING TREATED WITH 9 PREVIOUS TARGET COILS (STRYKER) THROUGH BOSTON SCIENTIFIC'S SL-10 MICRO CATHETER. THE PHYSICIAN WAS USING THE CASHMERE 9X22 AS HIS 10TH COIL AND DIDN'T LIKE THE WAY IT WAS FITTING INTO THE ANEURYSM. AS COIL WAS BEING WITHDRAWN, RESISTANCE WAS NOTED. AS THE COIL WAS HALF IN THE ANEURYSM AND HALF IN THE MICROCATHETER HE NOTICED THAT THE COIL HAD FRACTURED. THE COIL DELIVERY WIRE AND SHEATH WERE WITHDRAWN COMPLETELY AND THE REST OF THE COIL THAT WAS HALF IN THE ANEURYSM WAS RETRIEVED WHEN THE MICROCATHETER WAS WITHDRAWN FROM THE PATIENT. ONLY THE COIL DELIVERY WIRE AND SHEATH WERE SAVED, THE FRACTURED COIL WAS INADVERTENTLY THROWN AWAY. NO OTHER MICRUS COIL WAS USED AFTER THAT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 INDICATED THAT NO ATTEMPT WAS MADE TO DETACH THE COIL AS THE CABLE WAS NOT CONNECTED AT THE TIME OF THE COIL'S FRACTURE. PATIENT WAS DOING FINE AFTER THE PROCEDURE WAS COMPLETED. MEDICATIONS PRESCRIBED POST OP WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION G13538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention