BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS AMICA

    MDR report key: 15658023 · Received October 24, 2022

    Report

    Report Number
    0008010312-2022-00001
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 24, 2022
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A.
    Product Code
    GEI
    UDI-DI
    08033055147163
    PMA / PMN Number
    K182605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTO THE INSTRUCTIONS FOR USE IS REPORTED: CONTINUOUS ENERGY DELIVERIES LASTING MORE THAN 15 MINUTES ARE NOT PROVIDED FOR. HOWEVER, IF THE MEDICAL USER OF AMICA-GEN RESPONSIBLE FOR THE ABLATION TREATMENT EXECUTION, UNDER HIS/HER EXCLUSIVE RESPONSIBILITY, DECIDES TO PROLONG THE TREATMENT BEYOND THAT LIMIT, HE/SHE MAY RE-START THE TREATMENT (UPON APPROPRIATE MODIFICATION OF THE WORKING PARAMETERS SET, IF NEEDED) AND KEEP ON DELIVERING ENERGY UNTIL THE INTENDED THERAPEUTIC GOAL IS DEEMED TO BE REACHED. NEVERTHELESS, IT MUST BE SAID THAT THE PROLONGED USE OF THE SAME DISPOSABLE APPLICATOR, BEYOND THE MAXIMUM TIME PROVIDED FOR ITS CONTINUATIVE USE AND ESPECIALLY WHEN HIGH POWER DELIVERY IS IMPLICATED, MAY INCREASE THE RISK OF PROBE DAMAGE OR MALFUNCTION, DUE TO THE REMARKABLE THERMAL, MECHANIC, ELECTRIC AND ELECTROMAGNETIC STRESS TO WHICH THE APPLIED PART IS SUBJECT. AS REPORTED BY THE CUSTOMERS THE APPLICATOR HAS BEEN USED FOR TOTAL 32 MINUTES (3 INSERTIONS) BEFORE OBSERVING THE TIP DETACHMENT. THIS RISK IS CONTAINED IN OUR RISK ANALYSIS. THE OVERALL FREQUENCY OF DETACHMENTS OF SOME PART OF THE TIP IS APPROXIMATELY 10-3 IF APPLICATORS ARE USED FOR 15 MINUTES. THESE FREQUENCY IS COHERENT WITH OUR CURRENT APPROVED RISK ASSESSMENT, WHICH THEREFORE HAS NOT BEEN REVIEWED. THE RISK OF TUMORAL SEEDING ALONG THE NEEDLE TRACK IS INTRINSIC TO ALL PERCUTANEOUS DIAGNOSTIC OR THERAPEUTIC PROCEDURES, INCLUDING BIOPSIES AND THERMAL ABLATION PROCEDURES. THIS RISK IS WIDELY ACCEPTED IN VIEW OF THE EXPECTED CLINICAL BENEFIT FOR THE PATIENT ALSO WHEN CAUTERIZATION OF THE NEEDLE TRACK IS NOT FEASIBLE. AFTER A THERMAL ABLATION PROCEDURE THE RISK OF TUMORAL SEEDING IS FURTHER LOWERED BY: 1) TUMOR CELLS DESTRUCTION ENFORCED BY LOCAL ENERGY DELIVERY; 2) POSSIBILITY OF CAUTERIZING THE NEEDLE TRACK BY DELIVERING ENERGY WHILE WITHDRAWING THE NEEDLE FROM THE ABLATION SITE. IN THIS REPORTED EVENT TRACK ABLATION FAILED, BUT PRIOR ENERGY DELIVERY ENSURED TUMORAL CELLS DESTRUCTION, THEREFORE OUTRULING OR SUBSTANTIALLY DECREASING THE RISK OF SEEDING. WHEN THE TIP OF THE APPLICATOR IS RELEASED IN THE PATIENT BODY, THE PATIENT IS AT RISK OF MECHANICAL, CHEMICAL AND BIOLOGICAL INTERACTIONS BETWEEN THE OBJECT AND THE BODY. THE CHEMICAL RISK CAN BE REJECTED BECAUSE ALL THE COMPONENTS OF THE TIP, MADE OF ZIRCONIA, PTFE AND GOLD-COATED BRASS, ARE BIOCOMPATIBLE. THE BIOLOGICAL RISK CAN ALSO BE EXCLUDED BECAUSE THE APPLICATOR IS STERILE. THE RISK OF MECHANICAL INTERACTION CAN BE EVALUATED BY THE PHYSICIAN, WHO CAN DECIDE EITHER TO REMOVE THE TIP OR TO LET IT IN PLACE. IN MOST CASES, IT IS NEGLIGIBLE, BECAUSE THE BREAKAGE IN THE BODY HAPPENS DUE TO HARD, CARBONIZED TISSUES STICKING TO THE TIP. IN THIS CASE, ALSO, THE TIP IS EMBODIED IN A THICK LAYER OF CARBONIZED TISSUES SURROUNDED BY NECROTIZED TISSUES. CARBONIZED AND NECROTIZED TISSUES ARE HARD, THUS MAKING THE POSSIBILITY OF MIGRATION OF THE PIECE EXTREMELY UNLIKELY. THE FAILURE HERE CONSIDERED FALLS WITHIN CATEGORY P1.2 OF THE RISK ANALYSIS OF AMICA PROBE. IN VIEW OF THE FREQUENCY, DANGERS AND MITIGATIONS APPLIED AND OF THE BENEFITS OF THE TREATMENT, THE RESULTING RESIDUAL RISK IS LARGELY ACCEPTABLE.

    Description of Event or Problem · 0

    PATIENT UNDERGOING IMAGE GUIDED MICROWAVE ABLATION OF LIVER LESION. THE FIRST LESION WAS ABLATED AT 60WX10MIN. THE PROBE WAS THEN REPOSITIONED, AND THE ABLATION CONTINUED AT 80WX12MIN. THE PROBE WAS REMOVED AND POSITIONED IN THE SECOND LESION FOR AN ABLATION AT 80WX10MIN. THE PROBE WAS AGAIN REMOVED. CHAR WAS WIPED FROM THE SHAFT. NO DAMAGE TO THE TIP WAS NOTED. MULTIPLE PASSES WERE REQUIRED TO PLACE THE PROBE IN THE THIRD LESION, WHICH WAS ABLATED AT 80WX10MIN. UPON PROBE REMOVAL, IT WAS NOTED THAT TIP WAS NO LONGER ATTACHED. THE RETAINED TIP WAS VISIBLE IN CT IMAGING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? IMAGE GUIDED MICROWAVE ABLATION OF LIVER LESION. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147394 HS AMICA MICROWAVE TISSUE COAGULATION SYSTEM GEI H.S. HOSPITAL SERVICE S.P.A. AMICA-PROBE 41659 08033055147163

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other