BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 20310736 · Received September 26, 2024

    Report

    Report Number
    1317056-2024-00156
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    June 17, 2016
    Report Date
    March 5, 2025
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    UDI-DI
    H965750191
    PMA / PMN Number
    K062414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THIS 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/CATHETER DEVICE WAS RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF PORT/CATHETER 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. THIS SMARTPORT WAS MANUFACTURED IN OUR MANCHESTER FACILITY, WHICH IS NO LONGER IN OPERATION. CERTIFICATE OF CONFORMANCE FOR THE STERILIZATION PROCESS WAS VERIFIED TO BE APPROVED AT TIME OF DISTRIBUTION. 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 WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2016, (B)(6). UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, CATALOG NO.: CT80STPD, LOT NUMBER 4984172. UPON INFORMATION AND BELIEF, THE DEVICE WAS IMPLANTED BY (B)(6), CHEMOTHERAPY TREATMENT FOR BREAST CANCER. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED TO (B)(6), TO BE EVALUATED FOR A POSSIBLE PORT INFECTION, (B)(6) TEAM DETERMINED THAT THE PATIENT BE DISCHARGED AFTER SHOWING NO ADDITIONAL SIGNS OF REDNESS AND SWELLING AND SENT HOME WITH ANTIBIOTICS. ON OR ABOUT (B)(6) 2016, (B)(6), RETURNED TO (B)(6) AFTER EXPERIENCING WORSENING PAIN, IT WAS DETERMINED THAT DEFECTIVE PORT WAS INFECTED. UPON INFORMATION AND BELIEF, THE INFECTED PORT WAS THEN REMOVED BY (B)(6), AT THE SAME FACILITY. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, (B)(6) HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304407 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS 75019 4984172 H965750191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H| O