BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICESPHERE 1.5 CX 90 DEGREE

    MDR report key: 10593640 · Received September 28, 2020

    Report

    Report Number
    2134265-2020-13410
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    September 14, 2020
    Report Date
    November 18, 2020
    Manufacturer
    GALIL MEDICAL LTD
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE AMENDED IN THIS SUPPLEMENTAL REPORT: D4: LOT NUMBER WAS CONFIRMED TO BE U0508; D4: EXPIRATION DATE: 5/12/2022; H4: DEVICE MANUFACTURE DATE: 05/14/2020; H6: PATIENT CODE OF DISTENTION WAS ADDED TO CAPTURE THE SUBCUTANEOUS EMPHYSEMA. THE DEVICE WAS RETURNED FOR ENGINEERING ANALYSIS AND THE LOT NUMBER WAS CONFIRMED TO BE U0508. THE NEEDLE LOT DHR WAS REVIEWED, AND NO RELATED DEVIATION OR CONCERNS WERE FOUND. THE REVIEW DID NOT IDENTIFY ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT. VISUAL INSPECTION, LEAK TESTING AND NEEDLE DISASSEMBLY WAS PERFORMED. A CORROSIVE HOLE WAS IDENTIFIED IN THE NEEDLE SHAFT DUE TO THE PRESENCE OF SOLDERING FLUX FROM THE MANUFACTURING PROCESS, RESULTING IN THE REPORTED COMPLAINT. EXCESS FLUX IN A NEEDLE SHAFT LUMEN CAN LEAD TO THE DEVELOPMENT OF CORROSIVE HOLES IN THE NEEDLE SHAFT POST PRODUCTION. IT WAS CONFIRMED THAT THE CLINICIAN ONLY TESTED THE NEEDLE TIPS TO CONFIRM ICEBALL FORMATION AND WAS UNCLEAR ON THE CORRECT TECHNIQUE FOR INTEGRITY TESTING. THE IFU STATES THE FOLLOWING: 'BEFORE THE PATIENT IS ANESTHETIZED, NEEDLE INTEGRITY AND FUNCTIONALITY TESTS ON EACH CRYOBLATION NEEDLE AND THERMAL SENSOR MUST BE COMPLETED SUCCESSFULLY. A DEFECTIVE CRYOABLATION NEEDLE WITH GAS LEAK CAN CAUSE A GAS EMBOLISM IN THE PATIENT. SUCH NEEDLE MUST NEVER BE USED AND SHOULD BE RETURNED TO GALIL MEDICAL FOR EVALUATION,' 'PREPARE A LARGE BASIN (AT LEAST 30 CM IN DIAMETER) CONTAINING STERILE WATER OR SALINE TO CONDUCT THE NEEDLE TESTING,' 'PLACE THE NEEDLES, INDIVIDUALLY OR IN GROUPS, IN THE BASIN SUCH THAT THE FULL LENGTH OF THE NEEDLE IS SUBMERGED IN THE STERILE WATER OR SALINE.' GAS LEAKS FROM THE NEEDLE SHAFT HAVE BEEN NOTED IN THE HISTORIC COMPLAINT RECORDS. AN EXISTING CORRECTIVE ACTION PROJECT WAS PREVIOUSLY INITIATED FOR HOLES THAT WERE OBSERVED IN THE NEEDLE SHAFT &/OR VACUUM SLEEVE. AS A RESULT OF THE IMPROPER TESTING TECHNIQUE IDENTIFIED IN THIS EVENT, PRODUCT ADVISORY 92611185-FA WAS INITIATED TO REMIND USERS OF THE EXISTING NEEDLE INTEGRITY AND FUNCTIONALITY TESTING PROCESSES WHICH ARE FOUND IN THE IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRYOABLATION NEEDLE WAS OBSERVED TO HAVE A HOLE IN THE SHAFT DURING THE PROCEDURE WHICH LED TO EXTENSIVE SURGICAL EMPHYSEMA AND LEFT ARM NEUROPRAXIA. THE PROCEDURE WAS ABORTED PREMATURELY, RESULTING IN PROBABLE UNDERTREATMENT. SIX ICESPHERE CX NEEDLES WERE USED TO TREAT TWO LESIONS IN A SOLITARY KIDNEY CRYOABLATION PROCEDURE. THE NEEDLES WERE TESTED PRIOR TO THE PROCEDURE BY SUBMERGING THE TIP OF THE NEEDLE TO CONFIRM ICE FORMATION. AFTER THE FIRST FREEZE/THAW CYCLE OF THE PROCEDURE, A HOLE WAS OBSERVED IN THE SHAFT APPROXIMATELY 5CM FROM THE HUB OF ONE OF THE NEEDLES. THIS RESULTED IN WIDESPREAD SURGICAL EMPHYSEMA THROUGHOUT THE CHEST AND ABDOMEN FROM ARGON GAS INSUFFLATION, WHICH WAS VISIBLE ON THE FIRST TREATMENT SCAN AT FIVE MINUTES AND REQUIRED ASPIRATION. THE PROCEDURE WAS ABORTED AFTER ONLY ONE TREATMENT CYCLE AND THEREFORE THE PHYSICIAN BELIEVES THE TWO LESIONS WERE LIKELY UNDERTREATED. THE PATIENT ALSO EXPERIENCED LEFT ARM NEUROPRAXIA AS A RESULT OF THE MALFUNCTION. THE LEFT ARM NEUROPRAXIA IMPROVED WITH APPROXIMATELY 80% RESTORATION OF MOTOR FUNCTION AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. THE PATIENT IS SCHEDULED FOR FOLLOW UP IN ONE MONTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRYOABLATION NEEDLE WAS OBSERVED TO HAVE A HOLE IN THE SHAFT DURING THE PROCEDURE WHICH LED TO EXTENSIVE SURGICAL EMPHYSEMA AND LEFT ARM NEUROPRAXIA. THE PROCEDURE WAS ABORTED PREMATURELY, RESULTING IN PROBABLE UNDERTREATMENT. SIX ICESPHERE CX NEEDLES WERE USED TO TREAT TWO LESIONS IN A SOLITARY KIDNEY CRYOABLATION PROCEDURE. THE NEEDLES WERE TESTED PRIOR TO THE PROCEDURE BY SUBMERGING THE TIP OF THE NEEDLE TO CONFIRM ICE FORMATION. AFTER THE FIRST FREEZE/THAW CYCLE OF THE PROCEDURE, A HOLE WAS OBSERVED IN THE SHAFT APPROXIMATELY 5CM FROM THE HUB OF ONE OF THE NEEDLES. THIS RESULTED IN WIDESPREAD SURGICAL EMPHYSEMA THROUGHOUT THE CHEST AND ABDOMEN FROM ARGON GAS INSUFFLATION, WHICH WAS VISIBLE ON THE FIRST TREATMENT SCAN AT FIVE MINUTES AND REQUIRED ASPIRATION. THE PROCEDURE WAS ABORTED AFTER ONLY ONE TREATMENT CYCLE AND THEREFORE THE PHYSICIAN BELIEVES THE TWO LESIONS WERE LIKELY UNDERTREATED. THE PATIENT ALSO EXPERIENCED LEFT ARM NEUROPRAXIA AS A RESULT OF THE MALFUNCTION. THE LEFT ARM NEUROPRAXIA IMPROVED WITH APPROXIMATELY 80% RESTORATION OF MOTOR FUNCTION AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. THE PATIENT IS SCHEDULED FOR FOLLOW UP IN ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058137 ICESPHERE 1.5 CX 90 DEGREE UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD FPRPR3573 U0508

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R