BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 1883353 · Received June 15, 2010

    Report

    Report Number
    2954740-2010-00013
    Event Type
    Injury
    Date Received
    June 15, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 21, 2010
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF PRODUCT, VISUAL AND FUNCTIONAL WAS PERFORMED. THE COIL WAS RETURNED SEVERELY DAMAGED. THE SUTURE AND PROXIMAL SECTION OF THE COIL WERE SEVERED FROM THE REMAINDER OF THE COIL. THE COIL WAS FOUND STILL ATTACHED TO THE DEVICE POSITIONING UNIT (DPU). THIS MAY HAVE BEEN THE CONTRIBUTING FACTOR TO THE COIL STRETCHING DURING THE TIME, IT WAS ANCHORED IN THE COIL MASS DURING RETRACTION. THE UNIT PASSED ALL ELECTRICAL TESTING. THE DETACHMENT FIBER WAS FOUND TO HAVE NOT RECEIVED HEAT. ON THE FIRST DETACHMENT ATTEMPT, THE COIL DETACHED ON THE FIRST CYCLE AND THE DETACHMENT FIBER MELTED AS DESIGNED. THERE WERE NO MATERIAL OR PROCESS DISCREPANCIES FOUND. THEREFORE, THE ROOT CAUSE OF THE PROBLEM REPORTED WAS INCONCLUSIVE. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING 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: FOLLOWING A SUCCESSFUL DEPLOYMENT OF MICRUSPHERE AND ULTIPAQ MICROCOILS, DELTAPLUSH MICROCOIL WAS USED AS A FINISHING COIL FOR A SMALL SIZED ANEURYSM. THE COIL WAS SUCCESSFULLY PLACED AND UPON DETACHMENT, IT STRETCHED AND GOT CAUGHT IN THE COIL MASS DURING WITHDRAWAL. THE STRETCHED COIL WAS DRAGGED INTO THE PARENT VESSEL. A SOLITAIRE STENT HAD TO BE USED AS A SNARING DEVICE TO RETRIEVE THE COIL. THE STENT AND STRETCHED COIL WERE SUCCESSFULLY PULLED OUT. NO PT SEQUELAE WAS REPORTED. F/U REPORT RECEIVED INDICATED THAT THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION G10156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention