BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX COMPASS COMPLEX COIL (MCS)

    MDR report key: 1060736 · Received June 11, 2008

    Report

    Report Number
    2032493-2008-00010
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS. THE IMPLANT WAS RETURNED FOR EVALUATION ON 05/20/08. THE PUSHER WAS NOT AVAILABLE FOR EVALUATION. THE ATTACHMENT TETHER THAT HOLDS THE IMPLANT INTACT TO THE PUSHER IS BROKEN. THE TETHER IS WHITE/OPAQUE. THIS APPEARANCE IS CONSISTENT WITH BEING STRETCHED. THE IMPLANT IS NORMAL IN SPECIFICATION. THE MICROCATHETER APPEARS NORMAL, HOWEVER, THE DISTAL END HAS EVIDENCE OF BEING EXPOSED TO STRESS. THIS DEVICE APPEARS TO HAVE BEEN EXPOSED TO A RETRACTION FORCE THAT EXCEEDED THE MAXIMUM TENSILE SPECIFICATION OF THE MONOFILAMENT TETHER. HOWEVER, THE ROOT CAUSE CAN NOT BE DETERMINED AS THE PUSHER WAS NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    THE PHYSICIAN LOCATED A NEUROFORM 4X30 STENT ACROSS ANEURYSM NECK. THE MICROCATHETER WAS POSITIONED THROUGH STENT STRUTS. THE COIL WAS DEPLOYED AND PREMATURELY DETACHED. THE COIL WAS PARTIALLY LOCATED WITHIN ANEURYSM AND PARENT ARTERY. THE COIL WAS SNARED AND REMOVED WITHOUT DIFFICULTY. NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPLEX COMPASS COMPLEX COIL (MCS) EMBOLIZATION COIL HCG MICROVENTION, INC. 180612CM-V P0608213

    Patients

    Seq Age Sex Outcome Treatment
    1