BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2182235 · Received July 12, 2011

    Report

    Report Number
    2954740-2011-00035
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: AS THE COIL WAS BEING ADVANCED INTO THE MICROCATHETER, THE COIL DETACHED UNINTENTIONALLY INSIDE THE MICROCATHETER. THERE WAS NO DETACHMENT ATTEMPT WITH THE DETACHMENT CONTROL BOX REPORTED. NO PATIENT INJURY OCCURRED NOR ADDITIONAL MEDICATION ADMINISTERED PER ADDITIONAL REPORT RECEIVED FROM THE DISTRIBUTOR ON (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION F30273

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening