BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST TALON SEMI-FLEX

    MDR report key: 6093325 · Received November 10, 2016

    Report

    Report Number
    1056436-2016-00046
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 10, 2016
    Report Date
    February 17, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K010060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED WAS A TALON PROBE. ARRAYS 1, 2 & 3 OF THE PROBE WERE RECEIVED BROKEN AND MISSING. ARRAY 4 WAS INTACT BUT A BEND COULD BE SEEN AT THE SAME LOCATION AS THE OTHER THREE ARRAYS WERE BROKEN (APPROXIMATELY 1.1CM FROM TIP). THE BROKEN PORTION SEEM TO BE SIMILAR TO BENDING OF THE ARRAY BACK AND FORTH. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE DEVICE WAS CONNECTED TO A 1500X GENERATOR AND AN INTELLIFLOW PUMP. DURING THE TESTING, AN ERROR CODE FOR A BAD DEVICE WAS DISPLAYED DUE TO THE BROKEN ARRAYS. PURGING OF THE DEVICE'S INDIVIDUAL PORTS WAS UNSUCCESSFUL. EACH PORT WAS REMOVED FROM THE MANIFOLD TO ATTEMPT TO MANUALLY PURGE UNIT AND WAS UNSUCCESSFUL AS WELL. THIS COULD BE FROM DRIED SALINE AND/OR BIO MATERIAL. THIS IS ACCEPTABLE AS THIS IS NOT THE REASON FOR COMPLAINT AND IS TYPICAL WHEN PRODUCT IS RECEIVED USED. THE DEVICE HANDLE WAS DISASSEMBLED TO GAIN ACCESS TO THE TROCAR. THE TIP OF ARRAY 4 WAS BROKEN OFF DURING THE REMOVAL OF THE TROCAR. NO OTHER ENDS WERE RECOVERED. THE DEVICE DID PRESENT WITH SOME DIFFICULTY DEPLOYING, HOWEVER WITH ARRAY 4 BROKEN AND ATTACHED ONLY BY THE THERMOCOUPLE INSIDE, THE TIP WAS CATCHING ON THE OPENING IN THE TROCAR. AFTER TROCAR WAS REMOVED, THE ARRAYS WERE OBSERVED WITH SOME BIO MATERIAL PRESENT BUT NO OTHER VISUAL DEFECTS WERE OBSERVED THAT WOULD MAKE THE ARRAY DEPLOYMENT DIFFICULT. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION FOR "3 OF THE 4 ELECTRODES WERE BROKEN." IS CONFIRMED. "DIFFICULTY AND RESISTANCE TO MOVE FORWARD" WAS NOT CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE ARRAYS BEING BROKEN IS DUE TO TWISTING OR EXCESSIVE FORCE DURING USE. THIS DEVICE IS FULLY DEPLOYED IN THE DEVICE TRAY WHEN SHIPPED FROM THE MANUFACTURING FACILITY. THIS DOES NOT APPEAR TO BE THE RESULT OF A MANUFACTURING FAILURE. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT (4994742) FOR CATALOG NUMBER 700-102847 FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMED THAT THE PACKAGING LOT AND ALL COMPONENT LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATION THE INSTRUCTION FOR USE (160-103564, REV. 07), WHICH IS SUPPLIED TO THE USER WITH THIS CATALOG NUMBER, CONTAINS THE FOLLOWING STATEMENTS: INSPECT THE DEVICE FOR ANY DAMAGE. DO NOT USE A DEVICE THAT HAS BEEN DAMAGED. INSPECT THE TUBING SET PRIOR TO USE, DO NOT USE THE TUBING SET IF THERE IS AN EVIDENCE OF DAMAGE (E.G., KINKED, CRACKED, LEAKING, ETC). VERIFY CONNECTIONS BETWEEN TUBING SET AND DEVICE ARE SECURE. LOAD TUBING SET ON THE REUSABLE OCCLUSION BED ONTO THE PUMP HEAD. VERIFY TUBING ORIENTATION AND FLOW DIRECTION. REMOVE CAP ON TUBING SET SPIKE AND INSERT SPIKE IN THE SALINE BAG. HANG THE SALINE BAG ON THE IV POLE MOUNTED ON THE INTELLIFLOW PUMP. PURGE THE SYSTEM OF ALL AIR BUBBLES BY ALLOWING FLUID TO FREE FLOW THROUGH SYSTEM TO THE PUMP. ONCE THE SOLUTION FILLS THE TUBING SET, PULL THE PUMP LEVER FORWARD SECURING THE REUSABLE OCCLUSION BED ONTO PUMP HEAD. PRIME THE SYSTEM BY USING THE PURGE MODE ON THE RF GENERATOR. WITH THE DEVICE FULLY DEPLOYED TO THE 4-CM MARK, VERIFY CONTINUOUS FLOW OF FLUID FROM ALL FOUR (4) MICRO-INFUSION NEEDLES. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4). DEVICE NOT RETURNED TO DATE.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2016, THE TREATING PHYSICIAN INTRODUCED THE TALON INTO THE PATIENT'S CIRRHOTIC RIGHT LIVER ON 12 CM LENGTH UNDER ECHOGRAPHY VISION. THE PHYSICIAN ENCOUNTERED DIFFICULTY AND RESISTANCE WHEN TRYING TO PLACE THE PROBE. WHEN THE ELECTRODES WERE DEPLOYED AT 4 CM, IT WAS NOTED,UNDER FLUOROSCOPY, THAT 3 OF 4 ELECTRODES WERE BROKEN IN THE LIVER WITH NO POSSIBILITY TO REMOVE THE FRACTURED PIECES. HE CLOSED AND WITHDREW THE PROBE AND SET IT ASIDE. A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PATIENT IS FINE AND AWARE OF THE INCIDENT. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744563 STARBURST TALON SEMI-FLEX ELECTROSURGICAL PROBE GEI ANGIODYNAMICS 4994742

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other