BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX HYPERSOFT 10-SYSTEM COIL (MCS)

    MDR report key: 1013988 · Received March 13, 2008

    Report

    Report Number
    2032493-2008-00006
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 24, 2008
    Report Date
    February 25, 2008
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE PUSHER ASSEMBLY AND 2 V-GRIP DETACHMENT CONTROLLERS WERE RETURNED FOR EVALUATION ON MARCH 4TH, 2008. THE RETURNED PUSHER WAS VISUALLY ANALYZED UNDER MAGNIFICATION. THE PUSHER HAD A BENT/TWISTED APPEARANCE, WHICH LIKELY RESULTED FROM ATTEMPTS BY THE PHYSICIAN TO REMOVE THE PUSHER FROM THE MICROCATHETER. THE PUSHER CONTAINED A REMNANT OF THE PLASTIC THREAD/TETHER THAT NORMALLY ANCHORS THE IMPLANT TO THE PUSHER. THE TETHER REMNANT HAS A MELTED APPEARANCE, WHICH IS THE NORMAL APPEARANCE AFTER ACTIVATION OF THE V-GRIP DETACHMENT CONTROLLER, HEATING/MELTING OF THE TETHER, AND SUBSEQUENT DETACHMENT OF THE EMBOLIZATION COIL. THE 2 V-GRIP DETACHMENT CONTROLLERS RETURNED FOR EVALUATION FUNCTIONED NORMALLY, AND IN ACCORDANCE WITH FINISHED PRODUCT SPECIFICATIONS. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED THE EMBOLIZATION COIL INTO AN ANEURYSM. THE COIL REPORTEDLY FAILED TO DETACH FROM THE DELIVERY PUSHER FOLLOWING MULTIPLE DETACHMENT ATTEMPTS. UPON WITHDRAWING THE COIL INTO THE MICROCATHETER, THE COIL DETACHED. THE COIL DETACHED PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE MICROCATHETER. THE PHYSICIAN FOUND THAT HE COULD NOT ADVANCE OR RETRACT THE COIL. THE PHYSICIAN FLUSHED THE MICROCATHETER, THEREBY DEPLOYING THE COIL INTO THE DISTAL ARTERIAL CIRCULATION. THERE WAS NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPLEX HYPERSOFT 10-SYSTEM COIL (MCS) EMBOLIZATION COIL HCG MICROVENTION, INC. 100203HS-V P0710153

    Patients

    Seq Age Sex Outcome Treatment
    1