BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2920024 · Received January 17, 2013

    Report

    Report Number
    2029214-2013-00040
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 20, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FIFTH IMPLANT COIL PREMATURELY DETACHED AS THE PHYSICIAN WAS RUBBING AND FLUSHING IT IN SALINE. THE DEVICE WAS DISCARDED.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25935 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-6-15-3D 9642947

    Patients

    Seq Age Sex Outcome Treatment
    1