BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 1963786 · Received December 22, 2010

    Report

    Report Number
    2029214-2010-00265
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 26, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR EVALUATION. 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 PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-080 8805424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN