BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELIX DETACHABLE COIL

    MDR report key: 1920774 · Received November 5, 2010

    Report

    Report Number
    2029214-2010-00237
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 9, 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 INVOLVED IN THIS EVENT WILL NOT BE 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 FROM THE PUSH WIRE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-1-HELIX 7781863

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK