BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2444890 · Received February 9, 2012

    Report

    Report Number
    2029214-2012-00048
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SEGMMENT OF THE CATHETER HAS BEEN EVALUATED AND CONFIRMED THAT THE CATHETER WAS BROKEN DUE TO EXCESSIVE TENSILE FORCES APPLIED DURING USE.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER APPROXIMATELY 21 MINUTES OF ONYX INJECTION WITH ONYX REFLUX, THE CATHETER BROKE OFF AT 15CM FROM THE DISTAL TIP DURING REMOVAL. THE BROKEN SEGMENT REMAINED IN THE PATIENT. NO PATIENT INJURY REPORTED.SAME EVENT AS MDR# 2029214-2012-00049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9411082

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability