BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 3161741 · Received June 11, 2013

    Report

    Report Number
    2029214-2013-00532
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 15, 2013
    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).

    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 OR VIA BREAKING THE HYPOTUBE (AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE); THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE. UPON REMOVAL OF THE DEVICE, THE IMPLANT COIL DETACHED. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262349 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-6-15-3D 9695235

    Patients

    Seq Age Sex Outcome Treatment
    1