BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 489166 · Received October 15, 2003

    Report

    Report Number
    489166
    Event Type
    Other
    Date Received
    October 15, 2003
    Date of Event
    November 1, 2002
    Report Date
    November 1, 2002
    Manufacturer
    BARD MEDICAL DIVISION C.R. BARD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS REMOVING A PORTA-CATHETER IN SURGERY. WHEN CATHETER WAS REMOVED, IT WAS NOTED THAT SOME PORTION OF THE TIP END WAS MISSING. PT WAS SENT TO SPECIAL PROCEDURES FOR REMOVAL. THE MISSING PORTION OF THE CATHETER WAS FOUND IN THE RIGHT PULMONARY ARTERY. IT WAS REMOVED UNDER X-RAY IMAGE GUIDANCE. THE PT HAD NO ILL EFFECTS FROM THE EVENT. THE TIME FRAME OF IMPLANTATION IS APPROPRIATE ACCORDING TO MFG GUIDELINES. THIS PARTICULAR CATHETER IS ROUTINELY USED AT THIS FACILITY WITH NO HISTORY OF PROBLEMS. THE DEVICE WAS NOT CHECKED BY THE BIOMEDICAL ENGINEERING DEPT FOLLOWING THIS INCIDENT. NOR WAS IT KNOWN IF THE POINT OF SEPARATION WAS EVALUATED TO SEE IF THE CAUSE OF THE BREAK COULD BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PORTA CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD MEDICAL DIVISION C.R. BARD 6.6 FRENCH PORTA-CATHETER 22JL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other