BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 18354528 · Received December 19, 2023

    Report

    Report Number
    18354528
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 26, 2023
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH PORTACATH PLACED FOR CHEMOTHERAPY. ALMOST TWO MONTHS LATER, THE PORT WOULD NOT FLUSH OR GIVE BLOOD RETURN. A PORT FLOW STUDY CONDUCTED REVELATED THE CATHETER PRESENT ON THE LEFT SIDE WITH THE TIP IN THE SUPERIOR VENA CAVA (SCV). INJECTION NOTED LEAKAGE OF CONTRAST ALONG THE SUBCLAVIAN VENOUS REGION CONSISTENT WITH DISRUPTION OF THE CATHETER TUBING. NO CONTRAST EXTENDED INTO THE DISTAL PORTION OF THE CATHETER INTO THE SVC/HEART. THE PATIENT EXPERIENCED TEMPERATURES OF 101.7 FAHRENHEITS WITH CHILLS FOUR DAYS LATER AND HAD THE PORT REMOVED THE SAME DAY. SYMPTOMS SUBSIDED AND THE PATIENT HAD NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497171 SMART PORT CT PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. CT80STPD-VI A2023006

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Female