BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM NYLON HELICAL DETACHABLE COIL

    MDR report key: 3232597 · Received July 18, 2013

    Report

    Report Number
    2029214-2013-00632
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION AND THE EVENT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333756 AXIUM NYLON HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR NC-2-3-HELIX 9734105

    Patients

    Seq Age Sex Outcome Treatment
    1