BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 1941657 · Received December 9, 2010

    Report

    Report Number
    2029214-2010-00255
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE COIL COULD NOT BE DETACHED. UPON REMOVAL, THE COIL DETACHED INSIDE THE CATHETER. NO PT 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-3-4-3D 8319330

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK