BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23092783 · Received September 19, 2025

    Report

    Report Number
    3008737795-2025-00024
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    July 31, 2023
    Report Date
    August 25, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW: PRODUCT MET SPECIFICATIONS PER DOCUMENTARY REVIEW. WITHOUT RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT. THE RELATED RISKS ARE IDENTIFIED IN OUR RISK MANAGEMENT FILE AND PROCEDURE CLEARLY DESCRIBED IN THE IFU. THEREFORE, COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION, UNVERIFIABLE (NO RETURN PRODUCT).

    Description of Event or Problem · 0

    ON OR ABOUT ON (B)(6) 2022, PATIENT UNDERWENT RIGHT INTERNAL JUGULAR PLACEMENT OF AN ANGIODYNAMICS XCELA STANDARD TITANIUM POWER INJECTABLE PORT CATHETER PRODUCT, WITH MODEL NUMBER: H965451030, AND LOT NUMBER: 151366000. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF CHEMOTHERAPY TO TREAT PATIENT'S COLON CANCER. ON OR ABOUT ON (B)(6) 2023, PATIENT PRESENTED TO (B)(6), WITH COMPLAINTS OF FULLNESS IN HER HEAD, EARS, AND NECK THAT STARTED TWO WEEKS PRIOR TO THIS VISIT. PATIENT ALSO COMPLAINED OF FEELING THAT HER NECK VEINS WERE POPPING OUT. ON OR ABOUT ON (B)(6) 2023, PATIENT UNDERWENT REMOVAL OF THE XCELA PORT BY DR. (B)(6), M.D., SECONDARY TO A BLOOD CLOT ASSOCIATED WITH THE XCELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561799 XCELA PORT LJT PFM MEDICAL CPP SA N/A 151366000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R