BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2200108 · Received August 10, 2011

    Report

    Report Number
    2029214-2011-00217
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING COIL DELIVERY, RESISTANCE ENCOUNTERED. THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM (CATHETER AND COIL). OUTSIDE OF THE PATIENT, THE COIL WAS FOUND DETACHED INSIDE THE CATHETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-22-50 3D 9408154

    Patients

    Seq Age Sex Outcome Treatment
    1