BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART PORT CT

    MDR report key: 20440859 · Received October 14, 2024

    Report

    Report Number
    1317056-2024-00173
    Event Type
    Death
    Date Received
    October 14, 2024
    Report Date
    October 21, 2024
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    H787CT80STPD0
    PMA / PMN Number
    K062414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 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/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/ASSEMBLY/CATHETER LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. STERILIZATION LOAD RELEASE RECORDS FOR PACKAGING LOT 5733844 WERE REVIEWED AND NO ISSUES WERE OBSERVED. 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. 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) 2022, PLAINTIFF'S DECEDENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER H787CT80STPD0, LOT NUMBER 5733844. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) HOSPITAL IN (B)(6), FOR ADMINISTRATION OF CHEMOTHERAPY. DECEDENT PRESENTED TO (B)(6) HOSPITAL WITH COMPLAINTS OF FEVER AND WEAKNESS. IT WAS DETERMINED BY DECEDENT'S MEDICAL TEAM THAT HE HAD AN INFECTION CAUSED BY THE SMARTPORT AND THAT THE DEFECTIVE DEVICE HAD TO BE REMOVED. DECEDENT'S DEFECTIVE SMARTPORT WAS REMOVED. ON OR ABOUT (B)(6), 2022, DECEDENT PASSED AWAY. THE DEATH CERTIFICATE LISTS SEPSIS AS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810061 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC CT80STPD 5733844 H787CT80STPD0

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Hospitalization| D| L| O