BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 2190958 · Received August 4, 2011

    Report

    Report Number
    2029214-2011-00202
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 16.2 CM FROM THE DISTAL TIP. THE APPEARANCE OF THE CATHETER IS CONSISTENT WITH A RUPTURE CAUSED BY CATHETER OVER-PRESSURIZATION EXCEEDING THE LIMITS OF THE CATHETER. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THE CATHETER RUPTURED DURING ONYX INJECTION. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2011-00203.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5065 9431718

    Patients

    Seq Age Sex Outcome Treatment
    1