BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEEDNET ICEROD 90 DEGREE NEEDLE

    MDR report key: 2121714 · Received May 18, 2011

    Report

    Report Number
    9616793-2011-00007
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 7, 2011
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K060144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #7289-002. THE OCCURRENCE RATE FOR THIS TYPE OF EVENT IS RARE. ALTHOUGH THE NEEDLES WERE NOT RETURNED FOR TESTING, THE MOST LIKELY CAUSE OF A NEEDLE NOT FORMING ICE IS DUE TO A BLOCKAGE, WHICH COULD BE TEMPORARY IN NATURE. THE MOST LIKELY AND PROBLEMATIC RISK TO A PT FROM A BLOCKED NEEDLE USED IN CRYOABLATION TREATMENT IS THE POTENTIAL FOR UNDER-TREATMENT. IF A CANCER IS UNDERTREATED, THE PT WOULD BE AT A HIGHER RISK OF LOCAL RECURRENCE OF THE CANCER. TO PREVENT THIS EVENT FROM HAPPENING, GALIL MEDICAL HAS THE FOLLOWING MITIGATIONS IN PLACE: GALIL'S PRODUCT LABELING INSTRUCTS USERS TO PERFORM THE NEEDLE INTEGRITY AND FUNCTIONALITY TEST PRIOR TO A PROCEDURE. DURING THE TEST, USERS ARE INSTRUCTED TO INSPECT FOR THE PROPER CREATION OF AN ICEBALL DURING THE FREEZE PHASE OF THE TEST, AND SHOULD BE ABLE TO EASILY IDENTIFY A BLOCKED NEEDLE BEFORE USING IT. GALIL'S PRODUCT LABELING, INCLUDING THE SYSTEM USER MANUAL AND THE CRYOABLATION NEEDLES' IFU, STATES: "CONTINUOUSLY MONITOR THE CRYOABLATION PROCEDURE USING IMAGING GUIDANCE SUCH AS DIRECT VISUALIZATION, ULTRASOUND, COMPUTERTOMOGRAPHY (CT), OR (WHEN USING MRI-COMPATIBLE NEEDLES ONLY) MAGNETIC RESONANCE (MR)". THE NEEDLE IFU ALSO INCLUDES INSTRUCTIONS TO CHECK FOR NEEDLE DAMAGE PRIOR TO USE. SPECIFICALLY, BENDING OR KINKING WHICH COULD LIMIT ARGON FLOW AND CAUSE THE PRODUCT TO NOT FORM THE EXPECTED AMOUNT OF ICE. IN THIS CASE, THE CORRECT PRE-PROCEDURE TESTING WAS CONDUCTED AND IMAGING WAS USED, BUT PT FOLLOW-UP DETERMINED THAT THE TUMOR DESTRUCTION WAS INCOMPLETE. BASED ON THIS, THE PT WILL BE RE-TREATED. IT SHOULD BE NOTED THAT CRYOTHERAPY CAN BE PERFORMED MULTIPLE TIMES WITHOUT COMPLICATIONS; THEREFORE, THE RISK OF UNDERTREATMENT BECOMING A "SERIOUS RISK" FOR THIS PT IS MINIMIZED.

    Description of Event or Problem · 1

    DURING A CRYOTHERAPY TREATMENT, FOUR NEEDLES WERE USED FOR A 3 CM TUMOR. ALL NEEDLES WERE POSITIONED CORRECTLY BUT DID NOT FORM A CORRECT ICEBALL. THE RESULT ON DAY 1 SHOWED AN INCOMPLETE DESTRUCTION OF THE TUMOR. PT WILL HAVE TO BE RETREATED. THE PHYSICIAN REPORTED THAT THE ICEBALL FORMED DURING THE TEST SEEMED CORRECT, BUT AN ABNORMAL ARGON CONSUMPTION WAS OBSERVED (90 BARS USED IN 2X10 MIN FREEZING). THE MACHINE WAS IMMEDIATELY CHECKED BY A TECHNICIAN OF THE DISTRIBUTOR AND NO LEAKAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEDNET ICEROD 90 DEGREE NEEDLE CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL LTD. FPRPR3224 7289-001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK