BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM)

    MDR report key: 8784800 · Received July 12, 2019

    Report

    Report Number
    1317056-2019-00092
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 27, 2019
    Report Date
    October 9, 2019
    Manufacturer
    ANGIODYNAMICS
    Product Code
    NEY
    UDI-DI
    H787700106002US0
    PMA / PMN Number
    K162449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED FOR EVALUATION WAS ONE SOLERO PROBE. AS RECEIVED, THE DISPOSABLE PROBE COAXIAL CABLE WAS CUT AWAY FROM THE PROBE HANDLE. DUE TO THE CONDITION OF THE DEVICE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION WAS CONFIRMED. THE DEVICE WAS INSPECTED AND THE LAST ½ MM OF THE TIP WAS MISSING. IT APPEARS TO BE A CLEAN BREAK. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION DURING ABLATION. TIP IS NOT DISCOLORED AND THE REST OF THE TIP IS INTACT. DURING THE SHAFT ASSEMBLY PROCESS EACH TIP IS INSPECTED FOR A COMPLETE, SHARP POINT. AFTER THAT TIME A PROTECTIVE SHEATH IS APPLIED FOR THE REMAINDER OF THE ASSEMBLY PROCESSES. AT SOME POINTS THE SHEATH IS REMOVED FOR A PROCESS STEP AND THEN PLACED BACK ON THE SHAFT. THE PART DRAWING FOR THE CERAMIC TIP DOES INDICATE THAT 0.5MM IS THE ACCEPTABLE LIMIT FOR TIP DAMAGE. SINCE THE COMPLAINT STATED THE TIP WAS LONGER WHEN INSERTED, THE BREAK WOULD HAVE OCCURRED DURING USE.TESTING ON SCRAP PARTS SHOW SIDE PRESSURE OR IMPACT ON THE TIP WILL CREATE THIS TYPE OF BREAK BUT SIGNIFICANT FORCE IS REQUIRED. LIGHT HITS AGAINST A HARD SURFACE DID NOT BREAK OFF SAMPLE TIPS. A DEFINITIVE ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED. 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. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE USER WITH THE SOLERO APPLICATORS CONTAINS THE FOLLOWING STATEMENT; "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 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. COMPLAINT # (B)(4).

    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. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    STATUS POST SOLERO MICROWAVE ABLATION OF THE LIVER, DR. NOTICED THAT WHEN HE PULLED THE APPLICATOR OUT FROM THE PATIENT THE CERAMIC TIP OF THE APPLICATOR WAS SHORTER THAN THE ORIGINAL TIP ENTERING THE PATIENT INITIALLY. LOCATION OF THE CERAMIC TIP IS ASSUMED TO HAVE REMAINED INSIDE OF THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE AND IS BEING OBSERVED. THE REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577524 SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (19CM) SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY ANGIODYNAMICS 5467380 H787700106002US0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other