BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM DETACHABLE COIL

    MDR report key: 1791560 · Received July 27, 2010

    Report

    Report Number
    2029214-2010-00160
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 3, 2010
    Report Date
    July 5, 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL DELIVERY, THE PHYSICIAN NOTED THE PROXIMAL END OF THE PUSHWIRE WAS LOOSE. THE COIL WAS WITHDRAWN AND DETACHED INSIDE THE CATHETER. THE CATHETER AND COIL WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-6-HELIX 8512982

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN