BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD CROSSER CTO RECANALIZATION CATHETER

    MDR report key: 3060239 · Received April 9, 2013

    Report

    Report Number
    MW5029754
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 9, 2013
    Manufacturer
    FLOWCARDIA, INC. A SUBSIDIARY OF BARC, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEFT FEMORAL ARTERIOGRAM OF POPLITEAL ARTERY FOLLOWED BY ANGIOPLASTY OF OCCLUDED POPLITEAL ARTERY. BARD CROSSER S6 PERIPHERAL CATHETER USED; IT BUCKLED AND FORMED A LOOP. THE SHEATH WENT ACROSS THIS AND BUCKLED AS WELL. RETRIEVED CATHETER THROUGH SHEATH AND WAS NOTED THE TIP HAD FRACTURED AND WAS RETAINED WITHIN THE POPLITEAL ARTERY. THE 0.014 WIRE PLACED AND BALLOONED VESSEL TO COMPLETE ARTERIOGRAM. AT THIS POINT, RADIOLOGIST WAS ASKED TO PERFORM PROCEDURE TO EXTRACT THE CATHETER TIP WITH A SNARE, BUT IT APPEARED TO BE EMBEDDED IN THE VESSEL WALL AND WAS THOUGHT TO BE SAFE TO LEAVE IN PLACE AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147831 BARD CROSSER CTO RECANALIZATION CATHETER CROSSER CATHETER DQY FLOWCARDIA, INC. A SUBSIDIARY OF BARC, INC. CRUS6A FCWF10008

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR