BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 3002630 · Received March 13, 2013

    Report

    Report Number
    2029214-2013-00229
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 AN AVM (ARTERIOVENOUS MALFORMATION). DURING ONYX INJECTION, IT WAS REPORTED THAT THE MARATHON CATHETER RUPTURED AND SEPARATED AT APPROXIMATELY 5CM FROM THE DISTAL TIP. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00228.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104638 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-060 9677224

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability