BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX

    MDR report key: 24480053 · Received March 2, 2026

    Report

    Report Number
    1319211-2026-00060
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    April 12, 2018
    Report Date
    May 13, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    UDI-DI
    H787P5305K0
    PMA / PMN Number
    K010189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL EMDR 1319211-2025-00060 WAS INADVERTENTLY REPORTED UNDER 1319211-2026-00060; THEREFORE, THIS FOLLOW UP (#2) IS BEING SUBMITTED FOR THE CORRECTION. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE 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 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 53 DAYS PRIOR TO THE PATIENT'S INFECTION. THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION OR PERFORMANCE ISSUE DURING THE IMPLANT PROCEDURE/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 53 DAYS 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. (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS VORTEX PORT CATHETER DEVICE, WITH MODEL NUMBER P5305K AND LOT NUMBER 5163667. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) FOR LACK OF VASCULAR ACCESS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), WITH COMPLAINTS OF CHEST AND NECK PAIN. BLOOD CULTURES WERE DRAWN FROM THE PORT SITE. PLAINTIFF WAS SUBSEQUENTLY DISCHARGED WITH A PRESCRIPTION FOR ANTIBIOTICS PENDING RESULTS OF THE BLOOD CULTURE. ON OR ABOUT (B)(6) 2018, PLAINTIFF RETURNED TO (B)(6) HOSPITAL IN (B)(6), DUE TO CONTINUED DISCOMFORT AND THE POSITIVE BLOOD CULTURES THAT WERE PREVIOUSLY DRAWN. SHE WAS DISCHARGED HOME ON ANTIBIOTICS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6), DUE TO ISSUES WITH THE ANTIBIOTICS SHE HAD BEEN PRESCRIBED. ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT AN ULTRASOUND, WHICH DEMONSTRATED A THROMBOSIS IN HER LEFT INTERNAL JUGULAR VEIN. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE VORTEX NEEDED TO BE REMOVED DUE TO INFECTION AND THROMBOSIS. ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT REMOVAL OF THE DEFECTIVE DEVICE. THE REMOVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL. AFTER HER PORT WAS REMOVED, PLAINTIFF CONTINUED TO EXPERIENCE COMPLICATIONS AND DAMAGES RESULTING FROM THE DEFECTIVE DEVICE, INCLUDING, BUT NOT LIMITED TO, SUPERIOR VENA CAVA SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606 VORTEX PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC. P5305K 5163667 H787P5305K0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| H| R| L