BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT CT

    MDR report key: 23088381 · Received September 18, 2025

    Report

    Report Number
    1317056-2025-00237
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    July 17, 2023
    Report Date
    December 22, 2025
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    15051684018111
    PMA / PMN Number
    K101017
    Adverse Event
    Yes
    Product Problem
    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 EXPERIENCED PORT SYSTEM OCCLUSION AND CATHETER TIP MALPOSITION CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS EVENT. NO PORT/CATHETER PRODUCT WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION SINCE THERE WAS NO REPORTED PORT DEVICE MALFUNCTION, JUST OCCLUSION/MALPOSITION. PORT SYSTEM OCCLUSION (E.G FIBRIN SHEATH FORMATION) IS CAUTIONED IN THE DEVICE DIRECTIONS FOR USE (DFU) AS POTENTIAL COMPLICATION FOR AN IMPLANTED PORT SYSTEM. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE INDICATED PACKAGING/CATHETER LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) THAT IS SUPPLIED WITH THIS PORT DEVICE CONTAINS THE FOLLOWING STATEMENTS: WARNINGS - ABSENCE OF A BLOOD RETURN OR A POOR BLOOD RETURN CAN BE A SIGN OF A POTENTIAL COMPLICATION SUCH AS OCCLUSION, KINKING, BREAKAGE, PINCH-OFF SYNDROME, FIBRIN FORMATION, THROMBOSIS OR MALPOSITION. THIS SHOULD BE EVALUATED PRIOR TO DEVICE USAGE. A BLOOD RETURN SHOULD BE PRESENT PRIOR TO USAGE OF DEVICE FOR ANY THERAPY OR TESTING. - IF THE PATIENT COMPLAINS OF PAIN, OR IF THERE IS SWELLING WHEN THE DEVICE IS FLUSHED OR WHEN MEDICATION OR CONTRAST MEDIA IS ADMINISTERED, EVALUATE THE DEVICE FOR INFILTRATION, PROPER NEEDLE PLACEMENT, AND POTENTIAL COMPLICATIONS SUCH AS OCCLUSION, KINKING, BREAKAGE, PINCH-OFF SYNDROME, THROMBOSIS OR MALPOSITION. FAILURE TO ASSESS THESE COMPLAINTS OR OBSERVATIONS CAN LEAD TO DEVICE FAILURE. PRECAUTIONS · 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: THESE COMPLICATIONS ARE WELL DOCUMENTED IN LITERATURE AND SHOULD BE CONSIDERED WHEN A VENOUS ACCESS DEVICE IS UTILIZED. AIR EMBOLISM CLOT FORMATION FIBRIN SHEATH INFECTION INFLAMMATION OCCLUSION THROMBOEMBOLISM THROMBOPHLEBITIS THROMBOSIS 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 PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER: (B)(4), LOT NUMBER: 5760651. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD, AT (B)(6), FOR THE PURPOSE OF ADMINISTERING CHEMOTHERAPY. ON OR ABOUT ON (B)(6) 2023, DECEDENT PLAINTIFF'S SMARTPORT WOULD NOT ASPIRATE. AS A RESULT OF THE FAILURE TO ASPIRATE, THE SMARTPORT WAS CHECKED AND DEMONSTRATED THAT THE CATHETER TIP RESIDED IN THE AZYGOUS VEIN. SINCE THE CATHETER TIP DEMONSTRATED MIGRATION FROM ITS ORIGINAL RIGHT ATRIUM PLACEMENT, PORT REVISION/REPOSITIONING WAS RECOMMENDED. ON OR ABOUT ON (B)(6) 2023, A FOLLOW-UP SVC VENOGRAPHY DEMONSTRATED COMPLETE SVC OCCLUSION AND AN ULTRASOUND OF THE RIGHT INTRAJUGULAR VEIN DEMONSTRATED OCCLUSION AS WELL. AS A RESULT OF THESE FINDINGS, DOCTORS RECOMMENDED HAVING THE SMARTPORT REMOVED. ON OR ABOUT ON (B)(6) 2023, DECEDENT PLAINTIFF'S DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), MD AT (B)(6) HOSPITAL. DECEDENT PLAINTIFF SUFFERED SUFFER PHYSICAL PAIN AND MENTAL ANGUISH, WHICH LASTED UNTIL HIS DEATH ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2843290 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC H787CT66PTPDVI1 5760651 15051684018111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R| O| L