BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23132142 · Received September 24, 2025

    Report

    Report Number
    3008797795-2025-00028
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    July 27, 2023
    Report Date
    September 24, 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 (B)(6), 2022, PATIENT UNDERWENT PLACEMENT OF A XCELA PORT CATHETER DEVICE BY WAY OF THE RIGHT INTERNAL JUGULAR VEIN, MODEL NUMBER H965451090, LOT NUMBER 148728000, FOR CHEMOTHERAPY. THE XCELA WAS IMPLANTED AT (B)(6) HOSPITAL IN (B)(6). ON OR ABOUT (B)(6), 2023, PATIENT WAS DIAGNOSED WITH AN ACUTE DEEP VEIN THROMBOSIS ("DVT") IN THE RIGHT INTERNAL JUGULAR VEIN. ON OR ABOUT (B)(6), 2023, IT WAS NOTED THAT THE CATHETER TUBING HAD COILED NECESSITATING SURGICAL REMOVAL. THE XCELA DEVICE WAS THEN REMOVED AT (B)(6) ON OR ABOUT (B)(6), 2023

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393602 XCELA PORT LJT PFM MEDICAL CPP SA N/A 148728000

    Patients

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