BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX

    MDR report key: 20509246 · Received October 22, 2024

    Report

    Report Number
    1317056-2024-00200
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    May 16, 2023
    Report Date
    October 22, 2024
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    H787SSDX16I0
    PMA / PMN Number
    K951814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2018, A VORTEX PORT CATHETER, LOT #5131154 WAS IMPLANTED IN PLAINTIFF'S LEFT SIDE CHEST. THE PROCEDURE WAS PERFORMED BY DR. (B)(6) AT (B)(6) CENTER. PLAINTIFF'S PORT CATHETER WAS REMOVED ON OR ABOUT (B)(6) 2023, BY DR. (B)(6), AT (B)(6) HOSPITAL OF THE, AS IT WAS NO LONGER NEEDED. AT THE TIME OF THE SURGICAL REMOVAL ON (B)(6) 2023, DR. (B)(6) HAD DIFFICULTY REMOVING THE VORTEX PORT. DURING THE REMOVAL, A PORTION OF THE VORTEX CATHETER BROKE AND REMAINED IN PLAINTIFF'S BODY, UNBEKNOWNST TO DR. (B)(6) OR PLAINTIFF. FOR SEVERAL WEEKS/MONTHS THEREAFTER, PLAINTIFF EXPERIENCED LEFT SIDE CHEST PAIN, PLEURITIC, AND PALPATIONS WHICH WOULD WORSEN WHEN PLAINTIFF LAID ON HIS LEFT SIDE. PLAINTIFF WAS TREATED FOR CHEST PAIN, PALPITATIONS AND SHORTNESS OF BREATH ON (B)(6) 2023 AT THE HOSPITAL OF (B)(6). IN THE COURSE OF HIS TREATMENT IN (B)(6) 2023, A CT WAS PERFORMED WHICH SHOWED "CALCIFIED RIGHT ATRIAL MASS SEEN ON ECHO SHOWING UP ON CT AS RETAINED FRAGMENT IN LEFT BRACHIOCEPHALIC VEIN". DUE TO THE LOCATION OF THE RETAINED FRAGMENT AND THE RISK TO PLAINTIFF FOR AN ATTEMPTED REMOVAL OF THE FRAGMENT, THE DECISION WAS MADE TO LEAVE THE RETAINED VORTEX FRAGMENT IN PLAINTIFF'S BODY. TO DATE, THE RETAINED FRAGMENT OF THE VORTEX REMAINS IN PLAINTIFF'S LEFT BRACHIOCEPHALIC VEIN. AS A RESULT OF HAVING THE VORTEX IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, AND HAS SUFFERED ECONOMIC LOSS, INCLUDING OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565842 VORTEX PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC SSDX-16-I 5131154 H787SSDX16I0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other