BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 22672753 · Received July 31, 2025

    Report

    Report Number
    3008737795-2025-00017
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    June 15, 2011
    Report Date
    July 30, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT PRODUCT REFERENCE/BATCH # AND RETURN PRODUCT, THE MANUFACTURER COULD NOT CONDUCT NEITHER PRODUCT INVESTIGATION NOR DOCUMENTARY REVIEW. THEREFORE, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT "EMBOLISM AND THROMBOSIS". 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) 2009, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT, REFERENCE H965451270, SERIAL NO. (B)(6). THE DEVICE WAS IMPLANTED AT (B)(6) FOR MEDICATION PLACEMENT. ON OR ABOUT (B)(6) 2011, PATIENT PRESENTED TO (B)(6) WITH PAIN AND WAS INITIALLY DIAGNOSED WITH A THROMBUS. PATIENT'S PHYSICIAN DETERMINED THE SOURCE OF THE ACUTE EMBOLISM AND THROMBOSIS WAS THE XCELA PORT THAT REQUIRED MEDICATION, CONTINUAL EVALUATION AND EVENTUAL REMOVAL. ON OR ABOUT (B)(6), 2012, PATIENT'S PORT WAS REMOVED BY DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55333 XCELA PORT LJT PFM MEDICAL CPP SA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention