BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2950016 · Received February 8, 2013

    Report

    Report Number
    2029214-2013-00118
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. THE PUSHER ASSEMBLY WAS FOUND BROKEN WITH THE RELEASE WIRE PULLED BACK AND LIKELY CAUSED THE COIL TO DETACH (WHICH IS AN ALTERNATE DETACHMENT METHOD STATED IN THE IFU).(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A RENAL ANEURYSM. IT WAS REPORTED THAT THE COIL DETACHED AS IT WAS ADVANCING THROUGH THE CATHETER HUB.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55212 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-18-40-3D 8803992

    Patients

    Seq Age Sex Outcome Treatment
    1