BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPORT

    MDR report key: 19643129 · Received July 1, 2024

    Report

    Report Number
    1317056-2024-00097
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 30, 2021
    Report Date
    August 8, 2024
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF 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 REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS, I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. THE PATIENT INFECTION WAS OBSERVED MORE THAN 5 WEEKS AFTER THE PORT IMPLANT PROCEDURE INDICATING THAT THE MANUFACTURING/PACKAGING/STERILIZATION OF THE PORT DEVICE IS LIKELY NOT A CONTRIBUTING FACTOR TO THE INFECTION. POTENTIAL SOURCE OF PORT INFECTION IS CARE/MAINTENANCE OF THE PORT DEVICE AND/OR PORT ACCESS (I.E. NON-ASEPTIC TECHNIQUE), WHICH IS CAUTIONED IN THE DEVICE DFU. 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) 2021, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT. THE DEVICE WAS IMPLANTED BY DR. (B)(6) M.D., AT (B)(6) HEALTH - (B)(6) CENTER IN (B)(6) FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HIMSELF TO (B)(6) HEALTH - (B)(6) CENTER IN (B)(6) MICHIGAN WITH COMPLAINTS OF PAIN, REDNESS, AND PORT SITE IRRITATION. PLAINTIFF DEVELOPED A PORT OR RESERVOIR INFECTION AND PORT EROSION. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS DEFECTIVE AND HAD TO BE REMOVED. ON OR ABOUT (B)(6) 2021, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6), M.D., AT (B)(6) HEALTH - (B)(6) CENTER IN JACKSON, MICHIGAN. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL 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
    565089 SMARTPORT PORT & CATHETER, IMPLANTED LJT ANGIODYNAMICS, INC

    Patients

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