BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2182228 · Received July 12, 2011

    Report

    Report Number
    2954740-2011-00037
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 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

    UPON RECEIPT OF PRODUCT, VISUAL INSPECTION WAS PERFORMED. INVESTIGATION REVEALED THAT THE FIRST COIL WAS RETURNED UNDAMAGED. THE SECOND COIL WAS REPORTED TO HAVE BEEN DISCARDED. HOWEVER, ANOTHER 18 SERIES COIL WAS FOUND INSIDE THE RETURNED MICROCATHETER. THE MOST LIKELY ROOT CAUSE OF THE TWO COILS BECOMING STUCK WAS DUE TO A BLOCKAGE INSIDE THE MICROCATHETER. THIS BLOCKAGE WAS FOUND TO HAVE BEEN THE THIRD COIL FOUND INSIDE THE MICROCATHETER. THE CIRCUMSTANCES OF HOW THIS COIL BECAME DETACHED INSIDE THE RETURNED MICROCATHETER USED IN THE CASE 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: DURING DEVICE INTRODUCTION INTO THE MICROCATHETER, THE COIL GOT STUCK AND DETACHED UNINTENTIONALLY INTO THE MICROCATHETER. THE COIL WAS SUCCESSFULLY WITHDRAWN WITH NO PT INJURY REPORTED.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 J10349

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening