BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART PORT CT

    MDR report key: 23063431 · Received September 16, 2025

    Report

    Report Number
    1317056-2025-00233
    Event Type
    Death
    Date Received
    September 16, 2025
    Date of Event
    July 24, 2023
    Report Date
    September 30, 2025
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    15051684018197
    PMA / PMN Number
    K062414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT INFECTION CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). NO PORT DEVICE WAS RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION, DAMAGE OR PERFORMANCE ISSUE DURING IN SITU USE/TREATMENT. A DEVICE HISTORY RECORD REVIEW OF THE INDICATED PACKAGING LOT REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. STERILIZATION LOAD RELEASE RECORDS WERE REVIEWED FOR THE PACKAGING LOT IN QUESTION; NO ISSUES WERE OBSERVED. THE PORT WAS IMPLANTED INTO THE PATIENT MORE THAN 14 MONTHS PRIOR TO THE PATIENT'S INFECTION. THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION OR PERFORMANCE ISSUE DURING USE. IF THE MANUFACTURING/PACKAGING/STERILIZATION OF THE PORT DEVICE IN QUESTION WAS TO CONTRIBUTE TO AN INFECTION IN THE PATIENT IT WOULD HAVE LIKELY OCCURRED SHORTLY AFTER THE IMPLANT DATE AND NOT MORE THAN 14 MONTHS LATER. DEVICE DIRECTIONS FOR USE (DFU) CAUTIONS THAT EACH ACCESS OF THE PORT SHOULD BE PERFORMED USING ASEPTIC TECHNIQUE, FOLLOWING THE INSTITUTIONS UNIVERSAL PRECAUTIONS. THERE IS NO INDICATION FROM THE REPORTED COMPLAINT THAT THE MANUFACTURING/PACKAGING/STERILIZATION OF THE PORT DEVICE COULD HAVE CONTRIBUTED TO THE PATIENT'S INFECTION. INFECTION IS CAUTIONED IN THE DEVICE DFU AS A POTENTIAL COMPLICATION OF PORT SYSTEM USE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) THAT IS PROVIDED WITH THE PORT DEVICE CONTAINS THE FOLLOWING STATEMENTS: WARNINGS: THE DEVICE IS TO BE IMPLANTED, USED, MAINTAINED, AND REMOVED IN STRICT ACCORDANCE WITH INSTITUTIONAL AND OR CENTERS FOR DISEASE CONTROL (CDC) GUIDELINES OR POLICIES. REUSE OF SINGLE-USE DEVICES CREATES A POTENTIAL RISK OF PATIENT OR USER INFECTIONS. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. DO NOT USE SYRINGES SMALLER THAN 10 ML SYRINGE WHEN ACCESSING THE PORT AS SYSTEM DAMAGE CAN OCCUR. FLUSHING OCCLUDED CATHETERS WITH SMALL SYRINGES CAN CREATE EXCESSIVE PRESSURES WITHIN THE PORT SYSTEM. PRECAUTIONS: CAREFULLY READ AND FOLLOW ALL INSTRUCTIONS PRIOR TO USE. STRICT ASEPTIC TECHNIQUE IS OF PARAMOUNT IMPORTANCE WHEN IMPLANTING ANY DEVICE. FOR PERIPHERAL PLACEMENT, IRRITATION TO THE VEIN, RESULTING IN POSTOPERATIVE THROMBOPHLEBITIS, HAS BEEN ASSOCIATED WITH GUIDEWIRE AND INTRODUCER INSERTION. WHEN USING PERCUTANEOUS INTRODUCERS: TO AVOID BLOOD VESSEL DAMAGE, DO NOT ALLOW THE PERCUTANEOUS INTRODUCER SHEATH TO REMAIN INDWELLING IN THE BLOOD VESSEL WITHOUT THE INTERNAL SUPPORT OF A CATHETER OR DILATOR. IF MORE THAN ONE DRUG IS TO BE ADMINISTERED, BETWEEN THE INDIVIDUAL DRUG APPLICATIONS, FLUSH THE SYSTEM WITH 5 TO 10 ML NORMAL SALINE FOR INJECTION TO PREVENT DRUG INTERACTIONS. AFTER ANY INFUSION, INJECTION OR BOLUS APPLICATION, THE SYSTEM SHOULD BE FLUSHED WITH NORMAL SALINE FOR INJECTION OR LOCKED WITH A HEPARIN SOLUTION PER INSTITUTIONAL PROTOCOL TO PREVENT THROMBOTIC OCCLUSION OF THE CATHETER. POTENTIAL COMPLICATIONS: USE OF AN ANGIODYNAMICS PORT SYSTEM INVOLVES POTENTIAL RISKS NORMALLY ASSOCIATED WITH THE INSERTION OR USE OF ANY IMPLANTED DEVICE OR INDWELLING CATHETER INCLUDING BUT NOT LIMITED TO: AIR EMBOLISM: CATHETER DISCONNECTION OR MIGRATION, CATHETER EMBOLIZATION, CATHETER FRAGMENTATION, CATHETER PINCH-OFF, CLOT FORMATION, DRUG EXTRAVASATION (LEAKAGE), EROSION OF VESSEL AND SKIN, IMPLANT REJECTION, INFECTION, INFLAMMATION, THROMBOEMBOLISM, THROMBOPHLEBITIS, THROMBOSIS, NECROSIS OF SCARRING OF SKIN OVER IMPLANT AREA, VESSEL TRAUMA. POST-OPERATIVE CARE THE INCISION SITE SHOULD BE MONITORED FOR SIGNS OF INFECTION, INFLAMMATION, HEMATOMA, DEVICE ROTATION OR EROSION. ROUTINE WOUND CARE SHOULD BE GIVEN TO THESE SITES. THE SMART PORT CT IMPLANTABLE PORT MAY BE USED IMMEDIATELY AFTER VERIFICATION OF CATHETER PLACEMENT. INSTRUCT PATIENT TO AVOID ANY HEAVY EXERTION OR STRENUOUS ACTIVITY DURING THE FIRST FEW DAYS AFTER SURGERY. GENERAL GUIDELINES: EACH ACCESS OF AN ANGIODYNAMICS SMART PORT CT IMPLANTABLE PORT SHOULD BE PERFORMED USING ASEPTIC TECHNIQUE. FOLLOW INSTITUTIONAL UNIVERSAL PRECAUTIONS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT CONTINUES TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT ON (B)(6) 2022, DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, WITH MODEL NUMBER: CT96STSDVI1, AND LOT NUMBER: 5726567. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6), M.D. AT (B)(6). THIS SMARTPORT DEVICE WAS COMPRISED OF A PORT BODY AND A SILICONE CATHETER. THE DEVICE WAS IMPLANTED FOR THE ADMINISTRATION OF CHEMOTHERAPY TO TREAT DECEDENT'S CANCER. ON OR ABOUT ON (B)(6) 2023, DECEDENT PRESENTED TO (B)(6), WITH COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. UPON EVALUATION, DECEDENT WAS DIAGNOSED WITH A PORT CATHETER INFECTION CAUSED BY THE SMARTPORT. DECEDENT'S BLOOD CULTURES DRAWN FROM THE PORT SITE REVEALED DECEDENT WAS INFECTED WITH STAPHYLOCOCCUS HOMINIS, RESULTING IN PROBABLE SEPTIC SHOCK. ON OR ABOUT ON (B)(6) 2023, DECEDENT UNDERWENT REMOVAL OF THE DEFECTIVE SMARTPORT AT (B)(6). THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D. ON OR ABOUT ON (B)(6) 2023, DECEDENT PASSED AWAY WHILE STILL HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668494 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC H787CT96STSDVI1 5726567   15051684018197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| D| R| H| O