BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELICAL DETACHABLE COIL

    MDR report key: 2690206 · Received August 10, 2012

    Report

    Report Number
    2029214-2012-00416
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Date of Event
    July 14, 2012
    Report Date
    July 16, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RETURNED FOR EVALUATION AND THE IMPLANT COILS WERE ALREADY DETACHED FROM THE PUSHER ASSEMBLY. (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT HAVE NOT BEEN RETURNED FOR EVALUATION. MODEL# AND LOT# OF OTHER COIL: MODEL#: QC-3-4-HELIX; LOT#: 9470093; DOM: 07/25/2011; EXP: 07/24/2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH COILS COULD NOT BE DETACHED DURING PROCEDURE AND WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-4-HELIX 9451823

    Patients

    Seq Age Sex Outcome Treatment
    1