BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 21119646 · Received January 9, 2025

    Report

    Report Number
    3008737795-2024-00023
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    January 3, 2023
    Report Date
    January 9, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    UDI-DI
    00764011098533
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING A DOCUMENTARY REVIEW CONDUCTED BY THE MANUFACTURER, IT HAS BEEN DETERMINED THAT THE PRODUCT MET ITS SPECIFICATIONS. HOWEVER, DUE TO THE ABSENCE OF THE RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, IT IS NOT POSSIBLE TO DEFINITIVELY CONFIRM THE REPORTED INCIDENT OF "THROMBOSIS." THE MOST LIKELY CAUSE APPEARS TO BE A COMPLICATION, WHICH IS CONSISTENT WITH THE RISKS IDENTIFIED IN OUR RISK MANAGEMENT FILE AND THE COMPLICATIONS CLEARLY OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). CONSEQUENTLY, THIS COMPLAINT IS CLASSIFIED AS "NO DEFINITIVE CONCLUSION" AND "UNVERIFIABLE" DUE TO THE LACK OF RETURNED PRODUCT. ITEM NUMBER, ITEM DESCRIPTION, LOT NUMBER, EXPIRATION DATE, MANUFACTURE DATE, UDI: (B)(4), XCELA POWER INJECTABLE PORT WITH 8F X 750 MM ATTACHABLE POLYURETHANE CATHETER AND SILICONE PLUGS, 150639000, 12/20/2026, 12/21/2021, 0764011098229.

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2022, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT (MODEL NUMBER H965451270, LOT NUMBER 150639) (B)(6), BY DR. (B)(6), M.D. THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING IV CHEMOTHERAPY FOR THE TREATMENT OF LUNG CANCER. ON OR ABOUT (B)(6) 2023, PATIENT PRESENTED TO (B)(6) CLINIC, TO UNDERGO A CT WITH CONTRAST SECONDARY TO SUDDEN SWELLING IN THE RIGHT ANTERIOR NECK. THE CT RESULTS INDICATED THERE WAS EVIDENCE OF RIGHT JUGULAR VEIN THROMBUS ALONG THE XCELA "TUBING." ON OR ABOUT (B)(6) 2023, PATIENT UNDERWENT REMOVAL OF THE XCELA PORT BY DR. (B)(6), M.D., SECONDARY TO RIGHT INTRAJUGULAR DEEP VEIN THROMBOSIS ASSOCIATED WITH THE XCELA PORT CATHETER. SUBSEQUENT TO THE PORT REMOVAL, PATIENT BEGAN TAKING ELIQUIS, A BLOOD THINNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376396 XCELA XCELA INJECTABLE PORT LJT PFM MEDICAL CPP SA H965451270 150639000 00764011098533

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention