BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23649388 · Received November 25, 2025

    Report

    Report Number
    3008797795-2025-00034
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    January 10, 2010
    Report Date
    November 25, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT PRODUCT BATCH# AND RETURN PRODUCT, THE MANUFACTURER COULD NOT CONDUCT NEITHER PRODUCT INVESTIGATION NOR DOCUMENTARY REVIEW. 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) 2009, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PORT CATHETER PRODUCT, WITH MODEL NUMBER: H965451090, AND LOT NUMBER: T085191. THIS XCELA DEVICE WAS COMPRISED OF A PORT BODY AND A POLYURETHANE CATHETER. THE XCELA DEVICE WAS IMPLANTED BY DR. (B)(6), AT (B)(6), AND THE PURPOSE OF IMPLANTATION OF THE XCELA WAS TO ADMINISTER CHEMOTHERAPY. ON OR ABOUT ON (B)(6) 2010, PATIENT PRESENTED TO (B)(6), WITH COMPLAINTS OF NECK PAIN. PATIENT UNDERWENT A CT SCAN AND WAS DIAGNOSED WITH THROMBOSIS IN HER LEFT INTERNAL JUGULAR CATHETER. ON OR ABOUT ON (B)(6) 2010, PATIENT PRESENTED TO (B)(6), FOR REMOVAL OF THE XCELA DEVICE. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811752 XCELA PORT LJT PFM MEDICAL CPP SA N/A T085191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L