BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS AMICA

    MDR report key: 9748954 · Received February 25, 2020

    Report

    Report Number
    0008010312-2020-00002
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A.
    Product Code
    GEI
    UDI-DI
    08033055147163
    PMA / PMN Number
    K150112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: THE METALLIC TIP OF THE APPLICATOR IS MISSING. THE OUTER SURFACE OF THE CERAMIC IS VISIBLY BLACKENED ON ONE SIDE. PROBLEM CAUSE: THE DETACHMENT OF THE TIP OCCURS IN CASE OF TWO CONTEMPORARY FAILURE CONDITIONS: BREAKAGE OF THE CENTRAL CONDUCTOR OF THE COAXIAL LINE, TO WHICH THE TIP IS ATTACHED, AND FAILURE OF THE GLUE, WHICH HOLDS THE TIP TO THE BODY OF THE APPLICATOR. DURING MICROWAVE ABLATION, THE TEMPERATURE OF THE TISSUES ABUTTING THE APPLICATOR TIP OVERCOMES 100°C, CAUSING THEIR CARBONIZATION. CARBONIZED TISSUES BECOME HARD AND TEND TO STICK TO THE APPLICATOR TIP. WHEN THIS HAPPENS AND THE APPLICATOR IS MOVED, THE TIP UNDERGOES A STRAIN STRESS THAT MAY EXCEED ITS BREAKAGE LIMIT, TRIGGERING THE FAILURE CONDITIONS DISCUSSED IN THE ABOVE. SUCH STRAIN STRESS INCREASES WITH THE AMOUNT OF ENERGY DELIVERED BY THE APPLICATOR. CONSEQUENTLY, THE CHANCES OF TIP BREAKAGES INCREASE WHEN TREATING LARGE OR MULTIPLE LESIONS, IN PARTICULAR WHEN A HIGH ENERGY IS APPLIED FOR LONG TIMES AND/OR MULTIPLE ABLATIONS ARE PERFORMED WITH THE SAME APPLICATOR. RISK ANALYSIS: 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 ARE MADE OF BIOCOMPATIBLE MATERIALS. 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. ANOTHER RISK ASSOCIATED TO THE DETACHMENT OF THE TIP IS TUMOR "SEEDING", I.E. THE DISSEMINATION OF VIABLE TUMOR CELLS ALONG THE INSERTION PATH CAUSED BY THE IMPOSSIBILITY OF CAUTERIZING IT DURING THE WITHDRAWAL OF THE APPLICATOR ("TRACK ABLATION" MANEUVER), IF DESIRED. THESE ASPECTS ARE CONSIDERED IN THE RISK ANALYSIS OF THE DEVICE. COMBINING THE GRAVITY OF THE FAILURE WITH ITS FREQUENCY AND WITH THE EFFICACY OF THE APPLIED REMEDIES, THE RESULTING RESIDUAL RISK IS BELOW THE MINIMUM BENEFIT EXPECTED BY THE CLINICAL TREATMENT.

    Description of Event or Problem · 1

    MICROWAVE ABLATION OF PT WITH HCC, LIVER, SEG IV 4A, W/CIRRHOSIS, 1.0CM WAS ABLATED AT 100W/15M. TRACK ABLATION AT 40W / 4 S. AFTER AMICA 14G, 15CM WAS REMOVED, DR. NOTICED THAT THE DISTAL TIP REMAINED AT THE EDGE OF THE TUMOR ABLATION ZONE VERIFIED BY CT WAS NOT INTACT AND THE TIP OF THE PROBE WAS AT THE EDGE OF THE TUMOR ABLATION ZONE VERIFIED BY CT. THE POST CT SCAN W/CONTRAST SHOWED GOOD COVERAGE OF THE LESION. NO ADVERSE EVENTS NOTED FOR THE PATIENT A THIS TIME. FDA SAFETY REPORT ID#(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212811 HS AMICA APPLICATOR FOR MICROWAVE ABLATION GEI H.S. HOSPITAL SERVICE S.P.A. AMICA-PROBE 37011 08033055147163

    Patients

    Seq Age Sex Outcome Treatment
    1