BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23097358 · Received September 19, 2025

    Report

    Report Number
    3008797795-2025-00026
    Event Type
    Injury
    Date Received
    September 19, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    UNKNOWN
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW ON THE LIST OF BATCHES PROVIDED: NO DEVIATION WAS FOUND. 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) 2019, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT AT (B)(6) CLINIC IN (B)(6), BY DR. (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2019, PATIENT PRESENTED HIMSELF TO (B)(6) CLINIC IN (B)(6), WITH COMPLAINTS OF SWELLING AROUND THE PORT. PATIENT'S MEDICAL TEAM DIAGNOSED PATIENT WITH DEEP VEIN THROMBOSIS (DVT). AS A PART OF HIS TREATMENT PLAN, PATIENT'S MEDICAL TEAM PRESCRIBED AN ANTICOAGULANT TO TREAT THE PORT-RELATED DVT. PATIENT'S PORT WAS REMOVED ON OR ABOUT (B)(6) 2019. AT THE TIME PATIENT'S PORT WAS REMOVED ON (B)(6) 2019, A NEW XCELA PORT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760869 XCELA PORT LJT PFM MEDICAL CPP SA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention