BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTR FLOW HPC

    MDR report key: 446228 · Received March 4, 2003

    Report

    Report Number
    446228
    Event Type
    Death
    Date Received
    March 4, 2003
    Date of Event
    February 25, 2003
    Report Date
    March 3, 2003
    Manufacturer
    MICRO THERAPEUTIC INC
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH AVM. CATHETERIZATION ATTEMPTED WITH ULTRAFLOW MICRO CATHETER. AFTER FLUSHING WITH SALINE, A SUDDEN CHANGE IN PRESSURE WAS NOTED. PT WITH VESSEL RUPTURE AFTER CATHETER RUPTURE. PT WITH DIFFUSE SUB-ARACHNOID HEMORRHAGE, VENTRICULOMEGALY AND CONTRAST IN SUB-ARACHNOID SPACE. PT REMAINS IN HOSP WITH UNSTABLE NEUROLOGIC STATUS - SUB ARACHNOID HEMORRHAGE. PT EXPIRED IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTR FLOW HPC ANGIOGRAPHY CATHETER DQO MICRO THERAPEUTIC INC * 9303045

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death