BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 22461685 · Received July 9, 2025

    Report

    Report Number
    3008797795-2025-00013
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    November 15, 2023
    Report Date
    July 9, 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

    WITHOUT RETURNED PRODUCT AND BATCH#, THE MANUFACTURER COULD NOT CONDUCT PRODUCT INVESTIGATION, THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT "THROMBOSIS", AND BATCH RECORD CANNOT BE REVIEWED. THE RELATED RISK IS IDENTIFIED IN OUR RISK MANAGEMENT FILE. 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 AN ANGIODYNAMICS XCELA PRODUCT, MODEL/CAT. NUMBER H965451030. THE DEVICE WAS IMPLANTED AT (B)(6)FOR MEDICATION PLACEMENT. ON OR ABOUT (B)(6) 2024, PATIENT PRESENTED TO(B)(6) WITH PAIN AND WAS DIAGNOSED WITH SIGNIFICANT DIFFUSE THROMBUS WITH DEVELOPING THROMBOSIS SURROUNDING THE SVC VASCULAR ACCESS PORT CATHETER. PATIENT'S PHYSICIAN DETERMINED THE SOURCE OF THE ACUTE AND CHRONIC THROMBUS WAS THE XCELA PORT THAT REQUIRED MEDICATION AND REMOVAL. ON OR ABOUT (B)(6) 2024, PATIENT'S PORT WAS REMOVED BY DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544862 XCELA PORT LJT PFM MEDICAL CPP SA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention