BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM NYLON HELICAL DETACHABLE COIL

    MDR report key: 3002621 · Received March 13, 2013

    Report

    Report Number
    2029214-2013-00233
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH THE IMPLANT COIL STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS BROKEN AT THE PROXIMAL END WITH THE PROXIMAL BROKEN SEGMENT MISSING. THE DEVICE WAS EVALUATED AND FOUND WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER AND THE SECONDARY METHOD (PROVIDED IN THE INSTRUCTIONS FOR USE) WAS NOT ATTEMPTED. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104826 AXIUM NYLON HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR NC-4-10-HELIX 9521614

    Patients

    Seq Age Sex Outcome Treatment
    1