BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 1950248 · Received December 13, 2010

    Report

    Report Number
    2029214-2010-00264
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR EVAL. RADIO-OPACITY TEST WAS PERFORMED ON THE RETAINED SAMPLE FROM THE SAME LOT AND WAS FOUND TO BE WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    DURING PROCEDURE, IT WAS REPORTED THAT ONYX COULD NOT BE VISUALIZED UNDER THE FLUOROSCOPY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 8866643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK