BEUDAMED
    FDA Adverse Event Death Summary report: N

    FCHOON MULTIPURPOSE 7FR

    MDR report key: 37630 · Received September 3, 1996

    Report

    Report Number
    37630
    Event Type
    Death
    Date Received
    September 3, 1996
    Date of Event
    August 26, 1996
    Report Date
    August 31, 1996
    Manufacturer
    C.R. BARD, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING CARDIAC CATHETERIZATION. RIGHT HEART CATHETERIZATION PERFORMED WITHOUT INCIDENT. A 7FR MULTIPURPOSE CATHETER WAS THEN ADVANCED TO ASCENDING AORTA. AN ATTEMPT TO CROSS THE AORTIC VALVE RETROGRADE WAS UNSUCCESSFUL. SUDDENLY THE PT BECAME PROFOUNDLY HYPOTENSIVE; SHE ARRESTED, AND DESPITE VIGOROUS EFFORTS, SHE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FCHOON MULTIPURPOSE 7FR CATHETER FOR CARDIAC DQO C.R. BARD, INC. * 08NE 2645

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death