BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2483244 · Received February 20, 2012

    Report

    Report Number
    2954740-2012-00013
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON PRODUCT'S RECEIPT, VISUAL EVAL WAS CONDUCTED. VISUAL INSPECTION REVEALED THAT THE UNIDENTIFIED MICROCATHETER WAS NOT RETURNED. THE MICROCOIL SYSTEM WAS CLEANED BEFORE RETURN. THE COIL WAS RETURNED UNSHEATHED AND UNPROTECTED. THE COIL WAS ENTANGLED AND KNOTTED. THE COIL WAS UNTANGLED. LOCATED OFF THE PROXIMAL END AT 50.0 CM, 50.5 CM, 55.0 CM AND 6.0 CM ARE SEVERE KINKS ON THE WIRE. NO STRETCHING OR OTHER DAMAGE WAS FOUND TO THE COIL. THE COIL WAS RETURNED UNDAMAGED WITH NO STRETCHING OF THE PRIMARY WINDING. THEREFORE, THE ROOT CAUSE OF THIS COIL APPEARING TO STRETCH DURING REPOSITIONING CANNOT 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

    PER RECEIVED REPORT: WHILE AN ATTEMPT WAS MADE TO REPOSITION THE COIL, IT WAS NOTICED THAT IT APPEARED STRETCHED. THE COIL WAS SLOWLY RETRIEVED FROM THE COIL MASS AND PREVENTED ANY ADVERSE PT OUTCOME. NO PT INJURY REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION G10370

    Patients

    Seq Age Sex Outcome Treatment
    1