BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 25142563 · Received May 11, 2026

    Report

    Report Number
    3008797795-2026-00015
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    January 1, 2024
    Report Date
    May 11, 2026
    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

    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 (B)(6) 2023 PATIENT UNDERWENT PLACEMENT OF THE OF THE ANGIODYNAMICS XCELA, REF. H965451110, LOT 153065 000, THE DEVICE WAS IMPLANTED AT (B)(6). IN 2024, HER PORT WAS SUBSEQUENTLY REMOVED DUE TO THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538951 XCELA PORT LJT PFM MEDICAL CPP SA 153065000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R