BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEX

    MDR report key: 20516097 · Received October 23, 2024

    Report

    Report Number
    1317056-2024-00210
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    May 16, 2023
    Report Date
    October 31, 2024
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    H787SSDX16I0
    PMA / PMN Number
    K951814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED COMPLAINT DESCRIPTION OF CATHETER TUBING FRACTURED AND DETACHED CANNOT BE CONFIRMED SINCE NO COMPLAINT SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. POTENTIAL ROOT CAUSE FOR THE REPORTED CATHETER FRACTURE AND DETACHMENT FAILURE MODE IS PINCH-OFF SYNDROME, WHICH IS CAUTIONED IN THE DEVICE DFU. THE CATHETER AND LOCKING COLLAR ARE PROVIDED AS A SEPARATE COMPONENTS WITHIN THE PORT ASSEMBLY KIT. THE END USER ATTACHES THE CATHETER TUBING TO THE PORT (AND SECURES JUNCTION WITH LOCKING COLLAR) DURING THE IMPLANTATION PROCEDURE. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE INDICATED PACKAGING/ASSEMBLY/COMPONENT LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: THE INSTRUCTIONS FOR USE, (16605362-01) WHICH IS SUPPLIED TO THE USER WITH THIS CATALOG NUMBER, CONTAINS THE FOLLOWING STATEMENTS. CATHETER PLACEMENT CONSIDERATIONS: WARNING: AVOID MEDIAL CATHETER PLACEMENT INTO SUBCLAVIAN VEIN THROUGH PERCUTANEOUS TECHNIQUE. THIS PLACEMENT COULD LEAD TO CATHETER OCCLUSION, DAMAGE, RUPTURE, SHEARING, OR FRAGMENTATION DUE TO COMPRESSION OF THE CATHETER BETWEEN THE FIRST RIB AND CLAVICLE. CATHETER SHEARING HAS BEEN REPORTED WHEN THE CATHETER IS INSERTED VIA A MORE MEDIAL ROUTE IN THE SUBCLAVIAN VEIN. AFTER IMPLANTATION AND DURING SYSTEM USE EACH ACCESS TO THE VORTEX® MP PORT SYSTEM SHOULD BE PERFORMED USING ASEPTIC TECHNIQUE. · USE ONLY NON-CORING NEEDLES WITH THE VORTEX® MP PORT SYSTEM. THE NONCORING NEEDLE DESIGN HELPS MAINTAIN THE SELF-SEALING SEPTUM. UNDER QUALIFIED PROCEDURES THE VORTEX® MP PORT SYSTEM ALLOWS UP TO 2,000 PUNCTURES WITH AN ANGIODYNAMICS® 22 GAUGE NONCORING NEEDLE, WHEN TESTED AT 10 PSI. THIS PRESSURE EXCEEDS THE TYPICAL LEVELS EXPERIENCED IN CLINICAL PRACTICE. · DO NOT USE A SYRINGE SMALLER THAN 10 ML. SMALLER SYRINGES MAY CREATE AN OVER-PRESSURIZED CONDITION IN THE SYSTEM. WARNING: FOR CHEST PLACEMENT, AVOID MEDIAL CATHETER PLACEMENT INSTRUCTIONS FOR IMPLANTATION OF THE VORTEX® MP PORT INTO SUBCLAVIAN VEIN THROUGH PERCUTANEOUS TECHNIQUE. THIS PLACEMENT COULD LEAD TO CATHETER OCCLUSION, DAMAGE, RUPTURE, SHEARING, OR FRAGMENTATION DUE TO COMPRESSION OF THE CATHETER BETWEEN THE FIRST RIB AND CLAVICLE. CATHETER SHEARING HAS BEEN REPORTED WHEN THE CATHETER IS INSERTED VIA A MORE MEDIAL ROUTE TO THE SUBCLAVIAN VEIN. NOTE: A PORT PLACED TOO DEEPLY MAY BE DIFFICULT TO PALPATE AND ACCESS. POTENTIAL COMPLICATIONS: USE OF THE SYSTEM INVOLVES POTENTIAL RISKS ASSOCIATED WITH ANY IMPLANTED DEVICE OR INDWELLING CATHETER. THEY INCLUDE, BUT ARE NOT LIMITED TO: CATHETER FRAGMENTATION; CATHETER PINCH-OFF; EMBOLIZATION. 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 (B)(6) 2018, A VORTEX PORT CATHETER, LOT #5131154 WAS IMPLANTED IN PLAINTIFF'S LEFT SIDE CHEST. THE PROCEDURE WAS PERFORMED BY DR. (B)(6) AT (B)(6). PLAINTIFF'S PORT CATHETER WAS REMOVED ON OR ABOUT (B)(6) 2023, BY DR. (B)(6), AT (B)(6) HOSPITAL, AS IT WAS NO LONGER NEEDED. AT THE TIME OF THE SURGICAL REMOVAL ON (B)(6) 2023, DR. (B)(6) HAD DIFFICULTY REMOVING THE VORTEX PORT. DURING THE REMOVAL, A PORTION OF THE VORTEX CATHETER BROKE AND REMAINED IN PLAINTIFF'S BODY, UNBEKNOWNST TO DR. (B)(6) OR PLAINTIFF. FOR SEVERAL WEEKS/MONTHS THEREAFTER, PLAINTIFF EXPERIENCED LEFT SIDE CHEST PAIN, PLEURITIC, AND PALPATIONS WHICH WOULD WORSEN WHEN PLAINTIFF LAID ON HIS LEFT SIDE. PLAINTIFF WAS TREATED FOR CHEST PAIN, PALPITATIONS AND SHORTNESS OF BREATH ON (B)(6) 2023 AT THE (B)(6) HOSPITAL. IN THE COURSE OF HIS TREATMENT IN (B)(6) 2023, A CT WAS PERFORMED WHICH SHOWED "CALCIFIED RIGHT ATRIAL MASS SEEN ON ECHO SHOWING UP ON CT AS RETAINED FRAGMENT IN LEFT BRACHIOCEPHALIC VEIN". DUE TO THE LOCATION OF THE RETAINED FRAGMENT AND THE RISK TO PLAINTIFF FOR AN ATTEMPTED REMOVAL OF THE FRAGMENT, THE DECISION WAS MADE TO LEAVE THE RETAINED VORTEX FRAGMENT IN PLAINTIFF'S BODY. TO DATE, THE RETAINED FRAGMENT OF THE VORTEX REMAINS IN PLAINTIFF'S LEFT BRACHIOCEPHALIC VEIN. AS A RESULT OF HAVING THE VORTEX IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, AND HAS SUFFERED ECONOMIC LOSS, INCLUDING OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31399 VORTEX PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC SSDX-16-I 5131154 H787SSDX16I0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other