BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERO

    MDR report key: 19509067 · Received June 11, 2024

    Report

    Report Number
    1317056-2024-00083
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 28, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ANGIODYNAMICS
    Product Code
    NEY
    UDI-DI
    H787700106002US0
    PMA / PMN Number
    K162449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    RETURNED FOR EVALUATION WAS ONE (1) 19CM PROBE. AS RECEIVED, THE CERAMIC TIP WAS DETACHED. A PORTION OF THE CERAMIC TIP, SEMI RIGID CENTER CONDUCTOR, CERAMIC CYLINDER AND END WASHER HAVE DETACHED. THIS APPEARS TO BE A THERMAL EVENT THAT SEVERED THE CENTER CONDUCTOR, FRACTURED, AND DETACHED THE CERAMIC TIP. APPROXIMATELY 10 MM OF CERAMIC TIP REMAINS ATTACHED TO PORTION OF SEMI RIGID PROTRUDING FOR THE SHAFT. THERE WERE SIGNS OF OBVIOUS EXTERNAL PHYSICAL FORCES OR SIGNS OF ABNORMAL USE. THE CAUSE OF THIS TYPE OF THERMAL EVENT COULD NOT BE DEFINITIVELY DETERMINED. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF TIP FRACTURED AND DETACHED IS CONFIRMED. ROOT CAUSE FOR THE THERMAL EVENT/TIP DETACHMENT COULD NOT BE DEFINITIVELY DETERMINED. 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 INSTRUCTIONS FOR USE, ITEM NUMBER {16600972-01} WHICH IS SUPPLIED TO THE USER WITH THE SOLERO APPLICATORS CONTAINS THE FOLLOWING STATEMENTS: "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. "THE SOLERO MICROWAVE TISSUE ABLATION (MTA) SYSTEM AND ACCESSORIES ARE INDICATED FOR THE ABLATION OF SOFT TISSUE DURING OPEN PROCEDURES. 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. INSPECT THE APPLICATOR AFTER EACH ABLATION. IF THE APPLICATOR APPEARS DAMAGED, UTILIZE ANOTHER APPLICATOR FOR SUBSEQUENT ABLATIONS. WARNING: WHEN PLACING THE DEVICE, USE THE MINIMUM FORCE NECESSARY 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. DO NOT ENERGIZE THE APPLICATOR UNLESS THE ACTIVE REGION OF THE APPLICATOR IS FULLY INSERTED INTO TARGET TISSUE. IF THE APPLICATOR IS NOT PROPERLY LOCATED INTO THE SELECTED TISSUE, AN UNINTENDED THERMAL INJURY MAY OCCUR. 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 DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE PROCEDURE WAS AN OPEN SURGERY SETTING.APPLICATOR WAS USED IN AN INTRAOPERATIVE SETTING. PATIENT HAD 4 COLORECTAL METASTASES IN SEGMENT VIII. DUE TO DIFFICULTY OF ACCESS, AN ABLATION OF ALL 4 METASTASES WERE PLANNED. FIRST PLAN WAS TO USE ONE NEEDLE ON ALL 4 LESIONS BUT DUE TO DIFFICULTY OF ACCESS, WE DECIDED ON USING 1 NEEDLE FOR THE FIRST 2 LESIONS AND ANOTHER NEEDLE FOR THE REMAINING 2. WE ABLATED THE FIRST TUMOUR WITH 2MIN 60W ABLATION SUCCESSFULLY. THE FOLLOWING 2 LESIONS WERE CLOSE TO EACH OTHER SO IN ORDER TO NOT LOSE VISUALIZATION AFTER ABLATION OF THE FIRST TUMOUR WE INSERTED 2 NEEDLES AND ABLATED THE TUMOURS ONE AT A TIME. FIRST ABLATION WAS SUCCESSFUL (DONE WITH FIRST NEEDLE) AND SECOND ABLATION WAS SUCCESSFUL AS WELL (DONE WITH THE NEEDLE LOT 5810675). BOTH ABLATIONS WERE DONE WITH 2MIN 60W SETTING. WE REMOVED THE NEEDLE LOT 5810675 (VISUAL INSPECTION SHOWED NO SIGN OF DAMAGE IN THE TIP) AND INSERTED IT INTO THE LAST TUMOUR. WE PERFORMED THE LAST ABLATION WITH 6MIN 140W SETTING BUT NOTICED ON ULTRASONIC IMAGING THAT NO ABLATION WAS BEING DETECTED. WE RAN ANOTHER ABLATION WITH 6MIN 140W BUT AFTER APPROX. 4 MINUTES WE STOPPED THE ABLATION DUE TO NO RESULT AND ALSO MACHINE ONLY GIVING AN OUTPUT OF 100W. THE NEEDLE WAS REMOVED, AND VISUAL INSPECTION SHOWED THAT THE TIP OF NEEDLE HAD FALLEN OF AND WAS LEFT INSIDE THE PATIENT. WE CHANGED NEEDLES AND PERFORMED A FINAL SUCCESSFUL ABLATION OF THE LAST TUMOUR WITH 6MIN 140W AND LEFT THE TIP INSIDE THE LIVER. AT NO POINT DID THE MACHINE INDICATE ANY WARNINGS SUCH AS "COOLANT LIQUID HOT" OR "HIGH REFLECTED POWER" FOR NEEDLE LOT 5810675. THE MACHINE DID AT THE START OF TESTING TIP 1 GIVE AN ALERT OF "COOLANT LIQUID HOT" WHICH WE CORRECTED BEFORE ABLATION, TESTED TIP AGAIN AND NO ISSUE WAS ALERTED. THIS INDICATES THAT MACHINE SENSOR WORKS TO SOME EXTENT. NEEDLE TIP WAS LEFT INSIDE LIVER. NEEDLE REMOVAL WOULD HAVE DEMANDED A LARGER SURGICAL OPENING, DELAYED ANESTHESIA AND POSSIBLE TRAUMA TO THE LIVER. THE DECISION WAS MADE TO LEAVE TIP INSIDE PATIENT AND TO PERFORM A SCAN TO SEE IF IT IS IN AN ACCEPTABLE POSITION TO BE LEFT INSIDE OR WILL NEED TO BE REMOVED SURGICALLY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078337 SOLERO SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES, NEY ANGIODYNAMICS 700106002-US 5810675 H787700106002US0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown