BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIUMPH CIRCLE C

    MDR report key: 34978 · Received July 24, 1996

    Report

    Report Number
    34978
    Event Type
    Malfunction
    Date Received
    July 24, 1996
    Date of Event
    June 27, 1996
    Report Date
    July 23, 1996
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS BEING STRIPPED IN RADIOLOGY BECAUSE OF FIBRIN SHEATH SURROUNDING BOTH PORTS WHEN CATHETER TIP BROKE OFF AND BECAME LODGED IN PULMONARY ARTERY. PIECE COULD NOT BE RETRIEVED. PT WAS ASYMPTOMATIC. CATHETER WAS INSERTED VIA INTERNAL JUGULAR APPROACH. INSERTED IN ANOTHER FACILITY APPROX. 3 WEEKS PRIOR TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH CIRCLE C Implant PERMACATH LJT HORIZON MEDICAL PRODUCTS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR