BEUDAMED
    FDA Adverse Event Summary report: N

    VORTEX SMART PORT

    MDR report key: 1883744 · Received October 11, 2010

    Report

    Report Number
    1883744
    Date Received
    October 11, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PORT CATHETER PLACED IN LEFT SUBCLAVIAN. THE PATIENT RETURNED NINE MONTHS LATER FOR A NON-FUNCTIONING CATHETER. CHEST X-RAY REVEALED A FRACTURE OF THE CATHETER BETWEEN THE FIRST RIB AND THE CLAVICLE WITH TIP IN THE RIGHT ATRIUM. THE CATHETER WAS SUCCESSFULLY REMOVED THE FOLLOWING DAY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX SMART PORT CATHETER, IMPLANTED, PORT LJT ANGIODYNAMICS CT965TSD 994828

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO OTHER THERAPIES