BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-FLO CATHETER

    MDR report key: 37547 · Received August 29, 1996

    Report

    Report Number
    1217435-1996-00007
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Date of Event
    July 30, 1996
    Report Date
    August 1, 1996
    Manufacturer
    USCI DIV. C.R. BARD, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SHAFT OF THIS DEVICE KINKED WHILE ATTEMPTING TO CROSS THE HEART VALVE. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-FLO CATHETER ANGIOGRAPHY CATHETER DQO USCI DIV. C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR