BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEEDNET ICESEED RENAL KIT

    MDR report key: 1934695 · Received November 24, 2010

    Report

    Report Number
    9616793-2010-00022
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K042667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN PREPARATION FOR A US GUIDED RENAL CRYOABLATION CASE, THE SYSTEM WAS SET UP AND TESTED AND SEEMED TO BE FINE. THE TUMOR WAS MEASURED TO BE APPROX 3, 5 CM. FOUR ICESEED NEEDLES WERE PLACED IN THE TUMOR, AND THE FREEZING PROCESS WAS STARTED. THE TEMPERATURE STARTED TO DECREASE SLOWLY. AFTER SOME TIME, THE DOCTORS COMPLAINED ABOUT THAT THE FREEZING WAS TOO SLOW. AS AN INDICATION, THE TEMPERATURE WAS ONLY GOING DOWN TO - 8 C IN 15-20 MINUTES, AND THE DOCTORS COULDN'T SEE A BIG ICEBALL ON THE ULTRASOUND AS THEY ARE USED TO. THE DISTRIBUTOR CHECKED EVERYTHING THE GAS, TESTED NEEDLES FROM ANOTHER BADGE IN GROUP 5. NOTHING WAS WRONG. THE PHYSICIANS TRIED TO THAW FOR A MINUTE TO "FLUSH" ANY BLOCKAGE. THE DISTRIBUTOR ALSO CHANGED THE MACHINE FROM SEEDNET TO PRECISE, TO RULE IT OUT. NOTHING SEEMED TO HELP, AND THE FREEZING WAS NOT SUFFICIENT ENOUGH COMPARED TO THE DOCTOR'S EXPECTATIONS. IT ALL ENDED BY STOPPING THE PROCEDURE AND DECIDE TO REPEAT THE PROCEDURE IN A MONTH TIME. THE DISTRIBUTOR TESTED BOTH MACHINES AFTERWARDS, WITH THE SAME NEEDLES WHICH WERE USED FOR THE PT. IN BOTH CASES, IT WAS ABLE TO BUILD UP AN ICE BALL OF ABOUT 40 MM IN DIAMETER, WITHIN 5 MINUTES OF FREEZING, WITH THE 4 NEEDLES IN A SQUARE 5-10MM DISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEDNET ICESEED RENAL KIT CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL LTD. FPRPR3064 G5536-006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK