BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELIX DETACHABLE COIL

    MDR report key: 1972775 · Received January 28, 2011

    Report

    Report Number
    2029214-2011-00024
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 12, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. THE TACK WELD ON THE PUSHER ASSEMBLY WAS FOUND BROKEN. THE BROKEN TACK WELD LIKELY CAUSED THE COIL TO DETACH. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE COIL WAS FOUND LOOSE OUT OF THE PACKAGE. THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-8-HELIX 6300826

    Patients

    Seq Age Sex Outcome Treatment
    1