BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2023589 · Received March 18, 2011

    Report

    Report Number
    2029214-2011-00062
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    September 29, 2010
    Report Date
    February 24, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED.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-5-15-3D 7572942

    Patients

    Seq Age Sex Outcome Treatment
    1