BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PGLA 3D DETACHABLE COIL

    MDR report key: 2162685 · Received July 14, 2011

    Report

    Report Number
    2029214-2011-00179
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EVALUATED AND THE RELEASE WIRE WAS FOUND JAMMED IN THE PUSHER ASSEMBLY. THIS PREVENTED THE IMPLANT COIL FROM DETACHING. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE COIL COULD NOT BE DETACHED.NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM PGLA 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR PC-6-20-3D 9387700

    Patients

    Seq Age Sex Outcome Treatment
    1