BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 22470819 · Received July 10, 2025

    Report

    Report Number
    3008737795-2025-00015
    Event Type
    Injury
    Date Received
    July 10, 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 LEFT SUBCLAVIAN PLACEMENT OF AN ANGIODYNAMICS XCELA POWER INJECTABLE PORT CATHETER PRODUCT, WITH MODEL NUMBER H965451030, AND LOT NUMBER 15076900. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6), IN (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF CHEMOTHERAPY TO TREAT PATIENT'S BREAST CANCER. ON OR ABOUT (B)(6) 2022, PATIENT PRESENTED TO DR. (B)(6), M.D., (B)(6) ONCOLOGY IN (B)(6) FOR CHEMOTHERAPY TEACHING, WHERE PATIENT WAS NOTED TO HAVE AN INFECTION THAT REQUIRES REMOVAL OF THE XCELA. ON OR ABOUT (B)(6) 2022, PATIENT PRESENTED TO (B)(6) IN (B)(6), FOR REMOVAL OF THE INFECTED XCELA PORT. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120334 XCELA PORT LJT PFM MEDICAL CPP SA 15076900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention