BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 1200047 · Received October 15, 2008

    Report

    Report Number
    2029214-2008-00181
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 25, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION AND CONFIRMED THE IMPLANT COIL HAD DETACHED, BUT THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE COIL PREMATURELY DETACHED INSIDE THE CATHETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-22-50-3D 4586932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK