BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23095525 · Received September 19, 2025

    Report

    Report Number
    3008737795-2025-00025
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    July 3, 2024
    Report Date
    August 25, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    UDI-DI
    00000000000000
    PMA / PMN Number
    NO REF ID
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW OF RISK ANALYSIS. WITHOUT RETURNED PRODUCT AND REFERENCE/BATCH NUMBER, IT IS NOT POSSIBLE ADDITIONAL DOCUMENTARY REVIEW AND 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) 2021, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT, LOG: 1448833. THE DEVICE WAS IMPLANTED BY (B)(6), MD WITH (B)(6), MD MPH ASSISTING., AT (B)(6) UNIVERSITY - HEART AND VASCULAR - ADULT CATH LAB (CPRU), (B)(6). TO BE USED FOR TREATMENT FOR CHRONIC PANCREATITIS. ON OR ABOUT ON (B)(6) 2024, PATIENT PRESENTED HERSELF TO THE (B)(6) WITH A CHIEF COMPLAINT OF MALAISE FATIGUE WHERE SHE WAS DIAGNOSED WITH MIXTA CALIDA BACTEREMIA.

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2021 PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PORT PRODUCT, REFERENCE NUMBER H965451030, LOT NUMBER 149404. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD AND DR. (B)(6), MD, AT (B)(6) HOSPITALS AND CLINICS IN (B)(6) FOR VASCULAR ACCESS (BLOOD TRANSFUSIONS, IV FLUID DELIVERY). ON OR ABOUT (B)(6) 2023 (POSSIBLY (B)(6) 2024), PATIENT WAS DIAGNOSED WITH AN INFECTION. PORT REMOVAL WAS RECOMMENDED. ON OR ABOUT (B)(6) 2024 (POSSIBLY (B)(6) 2024), PATIENT'S PORT WAS REMOVED BY DR. (B)(6), (B)(6), MD AND DR. (B)(6), MD AT (B)(6) HOSPITALS AND CLINICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475504 XCELA PORT LJT PFM MEDICAL CPP SA N/A 149404 00000000000000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening