BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELICAL DETACHABLE COIL

    MDR report key: 2222692 · Received August 25, 2011

    Report

    Report Number
    2029214-2011-00222
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 22, 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

    ONLY THE PUSHWIRE WAS RETURNED FOR EVALUATION WITHOUT THE IMPLANT COIL ATTACHED. (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 HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-6-HELIX 9390125

    Patients

    Seq Age Sex Outcome Treatment
    1