BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT CT

    MDR report key: 22057457 · Received May 20, 2025

    Report

    Report Number
    1317056-2025-00129
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    December 19, 2022
    Report Date
    May 20, 2025
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    15051684018005
    PMA / PMN Number
    K062414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT SEPSIS 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 USE. A DEVICE HISTORY RECORD (DHR) 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 18 DAYS 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 18 DAYS LATER. IN ADDITION, THIS PATIENT HAS HAD A HISTORY OF BLOOD STREAM INFECTIONS. DEVICE DIRECTIONS FOR USE 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. 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. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) THAT IS PROVIDED IN THE SMARTPORT DEVICE CONTAINS THE FOLLOWING DIRECTIONS AND PRECAUTIONS: CONTRAINDICATIONS · CATHETER INSERTION IN THE SUBCLAVIAN VEIN MEDIAL TO THE BORDER OF THE FIRST RIB, AN AREA WHICH IS ASSOCIATED WITH HIGHER RATES FOR PINCH-OFF. 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. 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. · DO NOT ATTEMPT TO MEASURE THE PATIENT'S BLOOD PRESSURE ON THE ARM IN WHICH A PERIPHERAL SYSTEM IS LOCATED, SINCE CATHETER OCCLUSION OR OTHER DAMAGE TO THE CATHETER COULD OCCUR. · IF THE PATIENT COMPLAINS OF PAIN, OR 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 · CAREFULLY READ AND FOLLOW ALL INSTRUCTIONS PRIOR TO USE. · STRICT ASEPTIC TECHNIQUE IS OF PARAMOUNT IMPORTANCE WHEN IMPLANTING ANY DEVICE. 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: EROSION OF VESSEL AND SKIN IMPLANT REJECTION INFECTION 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 (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT, MODEL NUMBER H787CT75STSD0, LOT NUMBER 5753716. THE SMARTPORT WAS IMPLANTED BY DR. JAMES A. YORK, M.D., AT FORREST HEALTH. ON OR ABOUT DECEMBER 19, 2022, PLAINTIFF PRESENTED TO FOREST HEALTH WITH COMPLAINTS OF A FEVER. BLOOD CULTURES WERE OBTAINED AND RETURNED POSITIVE FOR MRSA, AND PLAINTIFF WAS DIAGNOSED WITH SEPSIS. HIS MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION. ON OR ABOUT (B)(6) 2022, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6) M.D., AT FOREST HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886316 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC H787CT75STSD0 5753716 15051684018005

    Patients

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