BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2222694 · Received August 25, 2011

    Report

    Report Number
    2029214-2011-00221
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    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 COIL HAS BEEN EVALUATED AND DETACHED NORMAL VIA MANUAL METHOD (PROVIDED IN THE INSTRUCTION FOR USE). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE COIL COULD NOT BE DETACHED DURING PROCEDURE AND WAS REMOVED FROM THE PATIENT.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 9399771

    Patients

    Seq Age Sex Outcome Treatment
    1