BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH IMPLANTABLE ACCESS SYSTEM

    MDR report key: 23058103 · Received September 15, 2025

    Report

    Report Number
    3012307300-2025-10651
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 22, 2025
    Report Date
    November 24, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    LJT
    UDI-DI
    10610586032776
    PMA / PMN Number
    K072657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D3: MFG ESTABLISHMENT NAME; ICU MEDICAL, INC. DEVICE EVALUATION: ONE PHOTO AND ONE USED DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. THE PROBABLE ROOT CAUSE IS DUE TO INCORRECT PLACEMENT OR IMPLANTATION OF CATHETER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL PLASTIC PARTS OF THE SYSTEM DETACHED AND ENTERED THE PATIENT'S BLOOD VESSELS. THE PATIENT RECEIVED A PORT-A-CATH AND CAME IN FOR A CHECK-UP BECAUSE THE TUBE APPEARED TO HAVE DETACHED FROM THE CHAMBER. HOWEVER, THE X-RAY SHOWED THAT THE CATHETER WAS BROKEN IN SEVERAL PLACES AND THAT PIECES OF THE CATHETER WERE IN THE LUNG. THE PORT COULD NOT BE REMOVED BECAUSE THERE WAS A HIGH RISK OF MORE PIECES OF TUBING EMBOLIZING INTO THE LUNGS. THE PORT MUST BE REMOVED SURGICALLY. AS IMMEDIATE MEASURES THE REPORTER ENUMERATES THE FOLLOWING: THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE DETACHED PIECES OF TUBING FROM THE LUNGS WERE RETRIEVED USING CATHETER TECHNOLOGY VIA A TRANSFEMORAL VENOUS ACCESS IN THE CARDIAC CATHETERIZATION LABORATORY (CCL). THE REMOVED PARTS WERE PRESERVED AND SECURED IN TUBES. ADDITIONALLY, FURTHER ACTION TAKEN WAS SURGICAL REMOVAL OF THE REMAINING DEFECTIVE PORT-A-CATH SYSTEM IS PLANNED AND THE PATIENT WILL BE CALLED IN FOR THIS. THE INCIDENT HAPPENED DURING THE REVISION OF THE PORT A CATH. THIS PRODUCT WAS INSERTED INTO THE PATIENT ON (B)(6) 2024. THERE WAS PATIENT INVOLVEMENT AND ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397677 PORT-A-CATH IMPLANTABLE ACCESS SYSTEM PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ICU MEDICAL, INC 4387747 10610586032776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H NOVALGIN 500MG| TEMESTA EXP. 1MG