BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) (19CM) (29CM)

    MDR report key: 6935051 · Received October 10, 2017

    Report

    Report Number
    1317056-2017-00084
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 12, 2017
    Report Date
    December 12, 2017
    Manufacturer
    ANGIODYNAMICS (GLENS FALLS)
    Product Code
    NEY
    UDI-DI
    H787700106002US0
    PMA / PMN Number
    K162449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE REPORTED DEFECTIVE DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE REPORTED COMPLAINT DESCRIPTION OF AN "ABLATION ZONE LARGER THAN EXPECTED" COULD NOT BE CONFIRMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT RECEIVING THE DEVICE TO EVALUATE, A ROOT CAUSE 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. A HARDWARE REVIEW OF THE ASSOCIATED GENERATOR WAS NOT PERFORMED AS THE SERIAL NUMBER OF THE UNIT WAS NOT PROVIDED BY HTE USER. WITHOUT A SERIAL NUMBER, A REVIEW OF THE UNIT'S HARDWARE SERVICE RECORDS CANNOT BE PERFORMED. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE USER WITH THE SOLERO APPLICATORS CONTAINS THE FOLLOWING STATEMENT; "CAUTION: THE OUTPUT POWER DISPLAY MAY DECREASE OVER TIME AS REFLECTED ENERGY CAN INCREASE OVER ABLATION PERIOD DUE TO CHANGES IN THE TISSUE." THE IFU ALSO GIVES EXAMPLES OF ABLATION ZONE SIZE FOR THE WATTAGE AND LENGTH OF TIME THE ABLATION IS PERFORMED. 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).

    Description of Event or Problem · 1

    AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: CUSTOMER REPORTED A LARGE PORTION OF LIVER ABLATED OUTSIDE OF THE MICROWAVE ZONE. DR. KIM PERFORMED TWO 4 MINUTE ABLATIONS AT 100W IN TWO DIFFERENT LESIONS. THE SECOND ABLATION WAS IN THE #8 SEGMENT OF THE LIVER AND TRAVELED ACROSS #4A AND PART OF SEGMENT #7 ALONG THE TRACKED OF THE APPLICATOR. THE PATIENT WAS RETURNED TO THE ICU. THE EVENT RESULTED IN A PROLONGED HOSPITAL STAY. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717092 SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) (19CM) (29CM) SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES, NEY ANGIODYNAMICS (GLENS FALLS) 17240738 H787700106002US0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention