BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 1963787 · Received December 22, 2010

    Report

    Report Number
    2029214-2010-00268
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 26, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING COIL DELIVERY, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN REMOVED THE COIL FOR HYDRATION AND THE COIL DETACHED. 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-3-4-3D 8214541

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK