BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 22470592 · Received July 10, 2025

    Report

    Report Number
    3008737795-2025-00014
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    August 16, 2018
    Report Date
    July 10, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW: PRODUCT MET SPECIFICATIONS PER DOCUMENTARY REVIEW. 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 ON (B)(6) 2018, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA POWER INJECTABLE PORT CATHETER, WITH MODEL NUMBER: H965451030, AND LOT NUMBER: 139956000. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6), FOR THE PURPOSE OF ONGOING INTRAVENOUS ACCESS TO TREAT PATIENT'S RHEUMATOID ARTHRITIS. ON OR ABOUT ON (B)(6) 2018, PATIENT PRESENTED TO (B)(6) WITH COMPLAINTS OF CHEST PAIN AND DYSPNEA ON EXERTION. DURING THE SAME VISIT, PATIENT UNDERWENT IMAGING, WHICH REVEALED SHE HAD BLOOD CLOTS, REQUIRING PATIENT TO UNDERGO A SURGERY TO REMOVE THE CLOTS, WHICH WAS UNSUCCESSFUL. PATIENT'S PHYSICIANS SUBSEQUENTLY PERFORMED A THORACOTOMY TO REMOVE THE BLOOD CLOTS. PATIENT HAD HER XCELA PORT REMOVED IN OR AROUND 2019. AT NO POINT DID THE PATIENT'S HEALTHCARE PROVIDERS INDICATE TO HER THAT HER PORT HAD FAILED. BECAUSE NO HEALTHCARE PROVIDER INFORMED THE PATIENT THAT THE XCELA WAS THE CAUSE OF HER THROMBOSIS, SHE HAD NO REASON TO BELIEVE THE THROMBOSIS COULD BE CAUSED BY XCELA UNTIL SHE DISCOVERED A POTENTIAL LEGAL CLAIM ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979036 XCELA PORT LJT PFM MEDICAL CPP SA 139956000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention