BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2180277 · Received July 27, 2011

    Report

    Report Number
    2029214-2011-00193
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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

    IT WAS REPORTED THE COIL COULD NOT BE DETACHED WITH AN INSTANT DETACHER OR VIA MANUAL (PROVIDED IN THE INSTRUCTION FOR USE). THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. 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-5-10-3D 7875396

    Patients

    Seq Age Sex Outcome Treatment
    1