BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 16586435 · Received March 21, 2023

    Report

    Report Number
    16586435
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 3, 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 UNDERWENT BILATERAL MASTECTOMY AND LEFT MEDIPORT REMOVAL. PATIENT RETURNED TO THE OPERATING ROOM FOR RE-EXCISION OF RIGHT BREAST 14 DAYS LATER. AN INTRA-OPERATIVE X-RAY WAS DONE. X-RAY SHOWED MEDIPORT METALLIC CUFF RETAINED FROM PREVIOUS SURGERY. PATIENT AND FAMILY MEMBER WERE NOTIFIED, CONSENT WAS OBTAINED, AND RETAINED PORT PIECE WAS REMOVED. PATIENT AND SURGEON CONFIRMED THAT RETAINED PIECE COULD BE PALPATED. DURING INSPECTION AND COMPARISON OF VORTEX ANGIODYNAMICS PORTS, THE MEDIPORT WITH THE METAL PIECE FALLS OFF THE CATHETER MORE EASILY VERSUS THE RUBBERIZED, BLUE TIP WHICH DOES NOT COME OFF AS EASY. THE MEDIPORT WITH THE METAL CUFFS ALSO COME UNATTACHED TO THE CATHETER IN THE PORT KIT AND HAS TO BE ATTACHED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11800 SMART PORT CT PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. CT66LTPD-VI 5740791

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA Female Other