BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX HELICAL SOFT

    MDR report key: 6201688 · Received December 23, 2016

    Report

    Report Number
    2032493-2016-00304
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    August 30, 2016
    Report Date
    November 22, 2016
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    00811425022085
    PMA / PMN Number
    K050954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE EMBOLIZATION COIL WOULD NOT DETACH AFTER APPROXIMATELY 6-8 ATTEMPTS WITH 3 DIFFERENT V-GRIP CONTROLLERS. AS AN ATTEMPT WAS MADE TO WITHDRAW THE COIL FROM THE ANEURYSM, THE COIL UNEXPECTEDLY DETACHED. THE IMPLANT COIL REMAINED IN POSITION WITHIN THE ANEURYSM AS INTENDED AND THE PUSHER WIRE WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY AND THE CURRENT PATIENT STATUS IS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851754 MICROPLEX HELICAL SOFT EMBOLIZATION COIL HCG MICROVENTION, INC. 100310HC-S-V-A-CN 160205E2 00811425022085

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR