BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PLATINUM 3-D DETACHABLE COIL

    MDR report key: 3800161 · Received May 8, 2014

    Report

    Report Number
    2029214-2014-00260
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION BROKEN INTO TWO SEGMENTS AT APPROXIMATELY 7.5CM FROM THE PROXIMAL END, BUT THE BROKEN SEGMENTS WERE RETAINED TOGETHER BY THE PULLED RELEASE WIRE. THE IMPLANT COIL WAS NOT ATTACHED TO THE PUSHWIRE. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE PUSHER ASSEMBLY WAS FOUND BROKEN WHICH POSSIBLY RETRACTED THE RELEASE WIRE AND LED TO THE DETACHMENT OF THE IMPLANT COIL. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    DURING THE PREPARATION, IT WAS REPORTED THE IMPLANT COIL PREMATURELY DETACHED AS IT WAS BEING HYDRATED. IT WAS ALSO NOTED THE MANUAL DETACHMENT METHOD LOCATION WAS FOUND TO BE BROKEN WITH THE RELEASE WIRE EXPOSED. NO PATIENT INJURY WAS REPORTED AS THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279221 AXIUM PLATINUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-8-3D 9735255

    Patients

    Seq Age Sex Outcome Treatment
    1