BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFLO VORTEX

    MDR report key: 23051185 · Received September 15, 2025

    Report

    Report Number
    1317056-2025-00235
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    December 25, 2023
    Report Date
    September 15, 2025
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    15051684016810
    PMA / PMN Number
    K190559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT INFECTION AND THROMBOSIS CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENTS (SAE). NO PORT DEVICE WAS RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION, DAMAGE OR PERFORMANCE ISSUE DURING IN SITU USE/TREATMENT. 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 MORE THAN 2 MONTHS 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 MORE THAN 2 MONTHS LATER. DEVICE DIRECTIONS FOR USE (DFU) 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. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) THAT IS PROVIDED WITH THE PORT DEVICE CONTAINS THE FOLLOWING STATEMENTS: 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. PRECAUTIONS · CAREFULLY READ AND FOLLOW ALL INSTRUCTIONS PRIOR TO USE. · STRICT ASEPTIC TECHNIQUE IS OF PARAMOUNT IMPORTANCE WHEN IMPLANTING ANY DEVICE. · 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: AIR EMBOLISM CATHETER DISCONNECTION OR MIGRATION CATHETER EMBOLIZATION CATHETER FRAGMENTATION CATHETER PINCH-OFF CLOT FORMATION DRUG EXTRAVASATION (LEAKAGE) EROSION OF VESSEL AND SKIN IMPLANT REJECTION INFECTION INFLAMMATION THROMBOEMBOLISM THROMBOPHLEBITIS THROMBOSIS 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) 2023, PLAINTIFF (B)(6) UNDERWENT AN INSERTION OF A LEFT INTERNAL JUGULAR TUNNELED VENOUS ACCESS PORT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODEL NUMBER CT80LPPDVI, LOT NUMBER 5796676. THE SMARTPORT WAS IMPLANTED AT (B)(6). PLAINTIFF AND HIS HEALTH CARE PROVIDERS USED THE SMARTPORT IN A NORMAL, CUSTOMARY, INTENDED, AND FORESEEABLE MANNER, NAMELY AS A SURGICALLY PLACED DEVICE USED TO MAKE IT EASIER TO DELIVER MEDICATIONS DIRECTLY INTO THE PLAINTIFF'S BLOODSTREAM. MOREOVER, PLAINTIFF'S HEALTH CARE PROVIDERS DID NOT PLACE OR MAINTAIN THE DEVICE INCORRECTLY SUCH THAT IT CAUSED THE DEVICE TO "PINCH OFF" OR OTHERWISE MALFUNCTION. ON OR ABOUT (B)(6) 2023, PLAINTIFF PRESENTED TO (B)(6) FOR TREATMENT OF A BLOOD CLOT/PULMONARY EMBOLISM, SEPSIS AND A STAPH EPIDERMIDIS INFECTION CAUSED BY HIS SMARTPORT DEVICE, THAT WAS CONFIRMED AND DIAGNOSED VIA CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) PE (PULMONARY EMBOLISM) PROTOCOL W/WO IV CONTRAST AND BLOOD CULTURES ON (B)(6) 2023. PLAINTIFF THEN SUFFERED ADDITIONAL PULMONARY EMBOLISMS OR THROMBOTIC EVENTS ON OR ABOUT (B)(6) 2025 AND AGAIN IN OR AROUND (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519111 BIOFLO VORTEX PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC H787CT80LPPDVI0 5796676 15051684016810

    Patients

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