BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERO MICROWAVE TISSUE ABLATION APPLICATOR

    MDR report key: 11337283 · Received February 17, 2021

    Report

    Report Number
    1317056-2021-00043
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 11, 2021
    Report Date
    February 26, 2021
    Manufacturer
    ANGIODYNAMICS
    Product Code
    NEY
    UDI-DI
    H787700106002US0
    PMA / PMN Number
    K162449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED FOR EVALUATION WAS A SOLERO PROBE. AS RECEIVED, THE CERAMIC TIP WAS NOT RETURNED WITH THE SAMPLE. THE TIP APPEARS TO HAVE BEEN INTENTIONALLY SNAPPED OFF BY THE END USER. THE CENTER CONDUCTOR IS NOT MELTED, BUT BENT OVER AND BROKEN. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED AS CONDITION OF THE RETURNED SAMPLE DID NOT ALLOW FOR FUNCTIONAL ABLATION TESTING, HOWEVER, THE HIGH REFLECTED POWER ERROR WAS CONFIRMED VIA EVALUATION OF PROBE ASSEMBLY. THE CERAMIC TIP WAS NOT PRESENT ON THE DEVICE AS RETURNED. A DETACHED TIP WAS NOT PART OF THE CUSTOMER COMPLAINT SO IT IS UNKNOWN WHERE THE TIP CAME APART FROM THE DEVICE. THE EVALUATION WAS DONE WITHOUT RUNNING THE DEVICE ON THE GENERATOR. THE CARTRIDGE COVER WAS REMOVED AND THE N-TYPE WAS INSPECTED. IF FLUID GETS INTO THE N-TYPE IT WILL TRIGGER AN HRP FAILURE. THE SCREW CAP WAS REMOVED AND THERE WAS NO EVIDENCE OF FLUID INGRESS. THE MCX COVER WAS THEN CUT AWAY TO EXPOSE THE MCX SHRINK BOOT. THE TC WIRE WAS SLIGHTLY BALLED UP UNDER THE TC, BUT THIS WAS NOT A TEMPERATURE RELATED COMPLAINT SO THIS DID NOT CAUSE ANY DEVICE OPERATIONAL ISSUE. NEXT THE MCX CAP WAS REMOVED. THE INSIDE OF THE MXC HAD FLUID PRESENT. THIS WILL TRIGGER AN HRP ERROR. THE SOURCE OF THE MOISTURE INGRESS IS NOT CERTAIN BUT THE GLUE LINED HEAT SHRINK BOOT ON THE MCX IS USED TO SEAL THE MCX TO CABLE CONNECTION. A POOR SEAL MAY ALLOW FLUID TO GET INTO THE CONNECTION. THE BOOT ON THIS DEVICE WAS POSITIONED HIGH UP ON THE MCX ABOVE THE SHOULDER (SEE RED ARROW). THIS WILL REDUCE THE CONTACT AREA ON THE WHITE CABLE JACKET. THE PROCESS WAS REVISED (B)(6) 2020 TO BETTER DEFINE THE BOOT LOCATION ON THE MCX. THE TOP OF THE BOOT IS TO BE SET AT THE SHOULDER OF THE MCX. THE ROOT CAUSE OF THIS EVENT IS RELATED TO A WORKMANSHIP ISSUE WITH THE MCX SEALING BOOT INSIDE THE HANDLE OF THE PROBE. THE DEVICE IN THE COMPLAINT WAS PRODUCED IN (B)(6) 2018, PRIOR THE MCX BOOT PLACEMENT CHANGE (CO-125661). ALL TEAM MEMBERS PERFORMING THIS WORK STEP ARE TRAINED TO THE CURRENT DOCUMENT REVISION. 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. LABELING REVIEW: THE INSTRUCTIONS FOR USE, 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. INSPECT THE SOLERO APPLICATOR'S PRE-ATTACHED TUBING SETS PRIOR TO USE. DO NOT USE THE DEVICE IF THE TUBING SETS HAVE ANY EVIDENCE OF DAMAGE (E.G. KINKS, CRACKS, ETC.). OBTAIN A MINIMUM OF 1000 ML OF STERILE CHILLED SALINE. 3000 ML CHILLED SALINE MAY ALSO BE USED TO INCREASE THE AMOUNT OF TIME BEFORE THE COOLING RESERVOIR NEEDS TO BE REPLACED. STERILE FLUID SHOULD BE CHILLED PRIOR TO PROCEDURE. TO ATTACH THE SINGLE USE TUBING TO A CHILLED-FLUID DELIVERY AND COLLECTION SYSTEM, REMOVE THE CAP ON TUBING SET SPIKE AND INSERT SPIKE IN THE SALINE SOURCE, BEING CAREFUL NOT TO PUNCTURE THROUGH THE SALINE SOURCE. TO ENSURE PROPER FLUID MOVEMENT HANG THE SALINE SOURCE HIGHER THAN THE GENERATOR (SUCH AS ON AN IV POLE). LOAD THE TUBING SET INTO THE SOLERO GENERATOR PUMP. THE PUMP CLIP ON TUBING SHOULD BE LOADED INTO THE PUMP CLIP HOLDER ON THE LEFT SIDE OF THE PUMP AND THEN CLOSE THE PUMP HOUSING COVER. PRIME THE TUBING SET BY TURNING THE PUMP ON AND MAKING SURE THERE ARE NO AIR BUBBLES PRESENT IN THE TUBING SET AND IN THE SALINE BAG PRIOR TO PLACING THE DEVICE IN THE TARGET TISSUE." 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

    ADDITIONAL INFORMATION PROVIDED CONFIRMED THE TIP DID NOT DETACH DURING THE PROCEDURE. IT WAS SUSPECTED A MEDICAL ATTENDANT PRESENT AT THE PROCEDURE SNAPPED IT OFF AFTER IT WAS REMOVED FROM THE PATIENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN END USER REPORTED AN ISSUE WITH A 19CM SOLERO APPLICATOR. DURING A PROCEDURE, THE PROBE WAS TESTED AND A "HIGH REFLECTED POWER" ERROR MESSAGE DISPLAYED INSTRUCTING TO REPOSITION THE APPLICATOR AND RETRY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME PROBE WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE DEVICE WAS RETURNED TO ANGIODYNAMICS FOR A DEVICE EVALUATION. A PRELIMINARY EXAMINATION OF THE DEVICE NOTED THE TIP OF THE APPLICATOR WAS MISSING. IT IS UNKNOWN WHERE THE CURRENT LOCATION OF THE TIP IS, THEREFORE AS A PRECAUTION, THIS REPORT IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233844 SOLERO MICROWAVE TISSUE ABLATION APPLICATOR SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES, NEY ANGIODYNAMICS 700106002-US 5359009 H787700106002US0

    Patients

    Seq Age Sex Outcome Treatment
    1