BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 3113783 · Received May 15, 2013

    Report

    Report Number
    2029214-2013-00462
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A FISTULA. DURING ONYX INJECTION, IT WAS REPORTED THAT THE MICROCATHETER HAD HOLES ALONG THE TUBE; THEREFORE, ONYX CAME OUT OF THE HOLES AND OCCLUDED THE EXTERNAL CAROTID. THE PHYSICIAN CONTINUED THE PROCEDURE WITH THE SAME ONYX, BUT ANOTHER APOLLO MICROCATHETER. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214010 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability