BEUDAMED
    FDA Adverse Event Summary report: N

    6 FR CATHETER

    MDR report key: 23482 · Received March 23, 1995

    Report

    Report Number
    23482
    Date Received
    March 23, 1995
    Date of Event
    March 17, 1995
    Report Date
    March 23, 1995
    Manufacturer
    USCI DIV. C.R. BARD, INC.
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPT TO SEAT CATHETER A KINK WAS NOTED ABOUT 2 INCHES ABOVE 6 FR INTRODUCER. KINK WAS REMOVED AND CATHETER REMOVED WITH WIRE. WHEN ATTEMPTING TO INTRODUCE A NEW CATHETER OVER A 035 ROSEN WIRE, RESISTANCE WAS MET, A NEW WIRE WAS TRIED AND AGAIN RESISTANCE MET (ALTHOUGH 6 FR SHEATH IN RT FEMORAL ART). A NEW PUNCTURE AND 6 FR SHEATH INSERTED. CATHETER INSERTED DURING ATTEMPT TO SEAT ANOTHER SMALL KINK. CATHETER WAS REMOVED. A NEW CATHETER WAS USED WITHOUT DIFFICULTY AND CASE WAS COMPLETED. THE PIG TAIL WAS REPOSITIONED AND AN AORTA BISTURICATION RUN WAS DONE. THE X-RAYS SHOWED NO DAMAGE TO VESSELS, ALTHOUGH THE MD INVOLVED STATES THERE IS CLINICAL SUSPICION OF A RETROGRADE DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 FR CATHETER CATHETER DQO USCI DIV. C.R. BARD, INC. JR4, AR-1 08KEO322

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR