BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH-1 PORT

    MDR report key: 299532 · Received October 11, 2000

    Report

    Report Number
    1056436-2000-00204
    Event Type
    Injury
    Date Received
    October 11, 2000
    Date of Event
    August 21, 2000
    Report Date
    September 6, 2000
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 9/14/00, THE MANUFACTURER (MFR) REC'D MEDWATCH REPORT #20-0033-2000-0003 FROM THE FACILITY THAT STATES THE FOLLOWING: THE DEVICE WAS PLACED IN 2000 WAS DETERMINED TO BE MALFUNCTIONING ON 8/14/2000. FLUOROSCOPY SHOWED IT WAS NO LONGER IN CENTRAL CIRCULATION AND ONLY 5 TO 6 CM. IN LENGTH AND RETRIEVED IN 2000. THE REMAINING 10CM OF CATHETER WAS FOUND VIA "PA" CHEST FILM TO BE TRANSECTED AND RESIDING IN THE RIGHT HEART. SURGICAL RETRIEVAL DONE IN 2000 IN ANGIO LAB WITH ENTRY IN RIGHT FEMORAL VEIN. SURGICAL IMPLANT OF NEW DEVICE DONE IN 2000. ON 10/10/2000, THE FACILITY'S RISK MGR INFORMED THE MFR'S PRODUCT COMPALINTS MGR THAT THE DEVICE WAS IMPLANTED IN THE RIGHT SUBCLAVIAN. THE PT HAD REC'D TWO (2) CHEMO TREATMENTS WITHOUT PROBLEMS. ON 8/14/00, THEY WERE UNABLE TO OBTAIN A BLOOD RETURN. THE DEVICE BODY WITH ATTACHED SEGMENT OF CATHETER WAS DISCARDED: HOWEVER, THE SEGMENT OF CATHETER RETRIEVED FROM THE PT'S HEART WAS AVAILABLE TO BE RETURNED TO THE MFR. FOR ANALYSIS. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-1 PORT VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA 3-528040H

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention