BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX 10-SYSTEM COIL (MCS)

    MDR report key: 3040535 · Received April 3, 2013

    Report

    Report Number
    2032493-2013-00016
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE DELIVERY PUSHER REVEALED THE COIL DETACHED FROM THE DELIVERY PUSHER. THE DELIVERY PUSHER IS KINKED AND TWISTED 3 CM FROM DISTAL END (3 CM MARK). THERE IS ALSO DAMAGE AT APPROX 1.5 CM FROM THE DISTAL END. THE TETHER THAT ATTACHES THE IMPLANT COIL TO THE DELIVERY PUSHER WAS BROKEN. THE MOST DISTAL SEGMENT OF THE BROKEN TETHER HAS CHARACTERISTICS OF STRENGTHENING VISIBLE. THE REMAINDER OF THE PUSHER WAS NORMAL IN SPECIFICATION. THE IMPLANT COIL WAS NOT RETURNED FOR EVAL AS IT REMAINS WITHIN THE PT. THE ROOT CAUSE OF THIS COMPLAINT APPEARS TO BE DUE TO THE DEVICE BEING EXPOSED TO A FORCE THAT EXCEEDED THE MAXIMUM TENSILE SPECIFICATION OF THE ATTACHMENT MONOFILAMENT. THE CATHETER USED WITH THIS DEVICE WAS NOT RETURNED FOR EVAL. WE CANNOT DETERMINE IF THIS WAS A CONTRIBUTING FACTOR. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON POSITIONING AN EMBOLIZATION COIL WITHIN AN ANEURYSM, THE COIL PREMATURELY DETACHED. A PORTION OF THE COIL REMAINED IN THE PARENT VESSEL. NO SECONDARY INTERVENTION WAS PERFORMED TO REMOVE THE COIL. THE PT WAS REPORTED TO BE IN STABLE CONDITION. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137049 MICROPLEX 10-SYSTEM COIL (MCS) EMBOLIZATION COIL HCG MICROVENTION, INC. 100308HS 130110H8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other