BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELIX DETACHABLE COIL

    MDR report key: 1920686 · Received October 25, 2010

    Report

    Report Number
    2029214-2010-00229
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 25, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVAL 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 PREMATURELY DETACHED DURING PREPARATION. THE DEVICE WAS NOT USED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-1.5-2-HELIX 8537655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK