BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERO

    MDR report key: 21026634 · Received December 27, 2024

    Report

    Report Number
    1317056-2024-00272
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 6, 2024
    Report Date
    April 28, 2025
    Manufacturer
    ANGIODYNAMICS
    Product Code
    NEY
    UDI-DI
    H787700106001US0
    PMA / PMN Number
    K162449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR 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 THE CERAMIC TIP WAS FRACTURED AND DETACHED IS CONFIRMED. THE APPLICATOR WAS RECEIVED WITH THE CERAMIC TIP DETACHED FROM THE DISTAL END OF THE SHAFT ASSEMBLY. APPROXIMATELY 4MM OF THE TIP REMAINED ATTACHED THERE ARE NO OBVIOUS SIGNS OF A THERMAL EVENT OCCURRING. THE CENTER CONDUCTOR AND END WASHER REMAINED ON THE DEVICE AND WAS INTACT. THE ZIRCONIA FERRULE WAS FRACTURED BUT REMAINED WITH THE DEVICE AS SHOWN BELOW AS THE CENTER CONDUCTOR PASSES THOUGH THE CERAMIC CYLINDER AND HOLDS THE CYLINDER CAPTIVE. THE ZIRCONIA FERRULE LIKELY FRACTURE WITH THE TIP FRACTURE EVENT. NO OBVIOUS CHARRING ON THE REMAINING PORTION OF THE TIP OBSERVED. THE CARTRIDGE WAS CONNECTED TO THE LAB SOLERO GENERATOR ALONG WITH THE PUMP CONNECTED TO THE PUMP TUBING. THE PUMP WAS STARTED AND PRIMED USING WATER TO TEST COOLANT FLOW, FLOW WAS OBSERVED TO FUNCTION NORMALLY. THE DEVICE WAS TESTED AT 140 WATTS FOR 20 SECONDS IN WATER, THE DEVICE ALLOWED A BRIEF TEST SESSION TO OCCUR AT 140 WATTS WITHOUT ANY ERRORS OCCURRING. IT WAS NOT FELT THAT RUNNING THE POWER TEST LONGER THAN 20 SECONDS WOULD NOT INCREASE ANY KNOWLEDGE ABOUT THE FAILURE. THERE WERE NO KNOWN MANUFACTURING DEFECTS FOUND, NOR SIGNS OF MISUSE DEVIATING FROM THE DFU. THE ROOT CAUSE OF THE TIP FRACTURE IS UNKNOWN. THE TIP WALL WAS OBSERVED TO BE INTACT, NO SIGN OF WEAKENED, CHARRED OR THINNED REGION. THE WALL THICKNESS APPEARS TO BE UNIFORM, THE OUTER SURFACE DID NOT INDICATE A THERMAL EVENT AS THERE WAS NOT ANY DISCOLORATION OF THE TIP ITSELF. IT IS UNKNOWN IF THIS FRACTURE OCCURRED DUE TO A THERMAL EVENT, METHOD OF USE OR AN UNKNOWN TYPE OF EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS; I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WHICH IS SUPPLIED TO THE USER WITH THE SOLERO APPLICATORS CONTAINS THE FOLLOWING STATEMENTS: INTENDED USE/INDICATIONS FOR USE: THE SOLERO MICROWAVE TISSUE ABLATION (MTA) SYSTEM AND ACCESSORIES ARE INDICATED FOR THE ABLATION OF SOFT TISSUE DURING OPEN, LAPAROSCOPIC, OR PERCUTANEOUS PROCEDURES. TESTING THE DEVICE: - PRIOR TO PLACING THE DEVICE IN THE TARGET TISSUE FOR ABLATION, PLACE THE TIP OF THE DEVICE (INCLUDING THE BLACK SHADED ZONE OF THE SHAFT) IN A CONTAINER OF STERILE WATER OR SALINE AND ACTIVATE THE DEVICE AT 100 WATTS FOR 10 SECONDS TO ENSURE THAT THE SYSTEM IS FUNCTIONAL. WARNING: DO NOT INITIATE THE PROCEDURE/ANESTHESIA UNTIL THE APPLICATOR HAS BEEN CONNECTED, PRIMED, AND THE GENERATOR STATUS BAR INDICATES "READY". PRECAUTIONS: AVOID PLACING LATERAL FORCES ON THE APPLICATOR TIP DURING PLACEMENT OR REMOVAL. ALWAYS USE THE LOWEST POWER AND SHORTEST TIME NECESSARY TO ACHIEVE THE TARGETED ABLATION. EACH APPLICATOR MAY BE USED TO ABLATE UP TO THREE SEPARATE AREAS OF TARGET TISSUE FOR EACH PATIENT AT THE MAXIMUM POWER AND TIME SETTING. INSPECT THE APPLICATOR AFTER EACH ABLATION. IF THE APPLICATOR APPEARS DAMAGED, UTILIZE ANOTHER APPLICATOR FOR SUBSEQUENT ABLATIONS. WARNING: DO NOT BEND THE APPLICATOR AS THIS MAY IMPAIR THE FUNCTION OF THE COOLING SYSTEM AND MAY DAMAGE THE MICROWAVE FEED LINE INSIDE THE APPLICATOR. WARNING: WHEN USING PERCUTANEOUSLY THE TIP OF THE ANTENNA MAY BE USED TO PUNCTURE THE SKIN AT THE POINT OF INSERTION. USE THE MINIMUM FORCE NECESSARY TO ACHIEVE THIS AND TAKE CARE NOT TO OVER ADVANCE THE APPLICATOR. REFER TO THE SHAFT DEPTH MARKINGS TO MONITOR PLACEMENT DEPTH. TAKE CARE TO NOT BEND THE TIP AS IT MAY CAUSE DAMAGE TO THE DEVICE. OPERATIONAL INSTRUCTIONS INSPECT ALL DEVICES AND PACKAGING FOR DAMAGE PRIOR TO USE. DO NOT USE ANY DEVICES THAT ARE DAMAGED OR IF THE STERILE BARRIER IS BREACHED. DO NOT USE THE SOLERO GENERATOR IF IT HAS BEEN DROPPED OR DAMAGED. WARNING: AFTER EACH ABLATION INSPECT THE APPLICATOR FOR ANY DAMAGE. IF ANY DAMAGE IS OBSERVED THE APPLICATOR SHOULD BE DISCARDED AND REPLACED WITH A NEW APPLICATOR. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5; DESCRIBE EVENT OR PROBLEM. D4; LOT NUMBER. D4; EXPIRATION DATE. H4; DEVICE MANUFACTURER DATE. REFERENCE (B)(4).

    Description of Event or Problem · 0

    A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. THE APPLICATOR HAD BEEN EASILY PLACED PERCUTANEOUSLY WITHOUT ANY TORQUING. THE UNIT WAS SET FOR 140W@4MINUTES. AS SOON AS THE PROCEDURE STARTED, THERE WAS AN AUDIBLE POPPING SOUND. NO ERROR CODES DISPLAYED. BY ULTRASOUND, IT LOOKED AS IF THE TISSUE WAS HEATING APPROPRIATELY. AT THE END OF THE ABLATION, AFTER THE PROBE WAS WITHDRAWN, IT WAS NOTED THE TIP HAD CLEANLY BROKEN OFF AT THE RADIOPAQUE HEATING ELEMENT AND THE CERAMIC TIP HAD BEEN RETAINED IN THE PATIENT'S LIVER. THE PROCEDURE WAS NOT CONTINUED DUE TO THIS EVENT. THE PATIENT WAS REPORTED AS STABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: ABLATION SIZE 4CM X 5CM. TOTAL ABLATION TIME: 140W@4MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513378 SOLERO SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY ANGIODYNAMICS 700106001-US 5831340 H787700106001US0

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male