BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 3033783 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00328
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT.THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS:MODEL: 105-7100-080 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AV (ARTERIOVENOUS) FISTULA. DURING ONYX INJECTION IN AN OFF LABEL TREATMENT CASE, IT WAS REPORTED THAT THE ECHELON CATHETER BECAME OCCLUDED AND RUPTURED WITH ONYX LEAKING OUT. THE ONYX INJECTION WAITING TIME WAS APPROXIMATELY 90 SECONDS AND SOME RESISTANCE WAS EXPERIENCED DURING ONYX INJECTION. NO INJURY WAS REPORTED WITH THE PATIENT AS THE ONYX LEAKED IN THE AREA THAT WAS SUITABLE FOR TREATMENT. SAME EVENT AS MDR# 2029214-2013-00327.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136713 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability