BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-FLO CATHETER

    MDR report key: 93587 · Received May 22, 1997

    Report

    Report Number
    1217435-1997-00166
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Report Date
    April 25, 1997
    Manufacturer
    USCI DIV C.R. BARD, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE SHAFT OF THIS DEVICE KINKED WHILE ATTEMPTING TO PASS THROUGH THE AORTIC VALVE WITHOUT A WIRE. IT WAS NECESSARY TO REMOVE BOTH THE SHEATH AND CATHETER IN ORDER TO COMPLETE THE PROCEDURE. A LARGE HEMATOMA WAS DETECTED AT THE INSERTION SITE AND A SCHEDULED PTCA WAS UNABLE TO BE PERFORMED. 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 UNKNOWN