BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

    MDR report key: 23660294 · Received November 26, 2025

    Report

    Report Number
    3008797795-2025-00036
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    August 24, 2024
    Report Date
    November 26, 2025
    Manufacturer
    PFM MEDICAL CPP
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW ON THE BATCH 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) 2023, UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA POWER-INJECTABLE PORT, REFERENCE NUMBER H965451830, LOT NUMBER 152410. THE DEVICE WAS IMPLANTED BY (B)(6), PA-C, AT THE (B)(6) MEDICAL CENTER IN (B)(6) MICHIGAN, FOR THE PURPOSE OF ONGOING VEIN ACCESS FOR CHEMOTHERAPY TO TREAT PATIENT'S SOFT TISSUE SARCOMA. PATIENT BEGAN TO SUFFER FROM PAIN AND CHRONIC THROMBUS. ON OR ABOUT (B)(6) 2024, PATIENT UNDERWENT A PROCEDURE, SPECIFICALLY A SUCTION THROMBECTOMY OF CATHETER RELATED THROMBUS AND PORT REMOVAL, AT THE (B)(6) MEDICAL CENTER IN (B)(6) MICHIGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148089 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT PFM MEDICAL CPP 152410000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L