BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 2840719 · Received November 20, 2012

    Report

    Report Number
    2029214-2012-00661
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Description of Event or Problem · 1

    EMBOLIZATION TREATMENT OF AN AVM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER RUPTURED AFTER INJECTING 0.3ML OF ONYX 18.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2012-00660.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability