BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX COMPLEX DIAMETER

    MDR report key: 4852992 · Received June 16, 2015

    Report

    Report Number
    2032493-2015-00089
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 22, 2015
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY PUSHER WAS RETURNED FOR EVAL WITH THE IMPLANT COIL DETACHED. THE DELIVERY PUSHER WAS FRACTURED AT THE MIDDLE SEGMENT. BOTH SEGMENTS WERE RETURNED. THE EVAL COULD NOT BE CONFIRMED AS THE DEVICE WAS DAMAGED AND THE COIL WAS NOT INCLUDED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    COILING TREATMENT WAS CONDUCTED OF AN ANEURYSM. UPON POSITIONING THE COIL, RESISTANCE WAS ENCOUNTERED. THE COIL WAS REPORTED TO STRETCH AND WAS OBSERVED TO HAVE PREMATURELY DETACH WITHIN THE MICROCATHETER. THE CATHETER AND COIL WERE REMOVED TOGETHER SUCCESSFULLY. NO INJURY WAS REPORTED WITH THE PT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392581 MICROPLEX COMPLEX DIAMETER EMBOLIZATION COIL HCG MICROVENTION, INC. 100512CC-V 1C011023

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR