BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 4973715 · Received August 5, 2015

    Report

    Report Number
    3004462490-2015-00018
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 27, 2013
    Report Date
    July 9, 2015
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    GALIL MEDICAL WAS NOTIFIED OF THIS COMPLAINT 2 YEARS AFTER THE CRYOABLATION PROCEDURE WAS CONDUCTED. THE NEEDLES WERE NOT RETURNED TO GALIL MEDICAL AND THEREFORE AN INVESTIGATION COULD NOT BE COMPLETED ON THE NEEDLES. THE PROCEDURE REPORT FROM THE VISUAL-ICE CRYOABLATION SYSTEM WAS RETRIEVED AND REVIEWED FOR ANY SYSTEM ABNORMALITIES THAT MAY HAVE OCCURRED DURING THE PROCEDURE. THE PROCEDURE REPORT INDICATES THAT TWO CRYOABLATION NEEDLES WERE USED FOR THE TREATMENT. BOTH NEEDLES UNDERWENT NEEDLE TESTING PRIOR TO THE PROCEDURE. THE PROCEDURE CONSISTED OF TWO FREEZE-THAW CYCLES WITH DURATIONS OF 10.5 MIN FREEZE / 5 MIN THAW / 14 MIN FREEZE / 5 MIN THAW. NO ANOMALIES WITH THE FREEZE-THAW CYCLES WERE RECORDED. THE NEEDLES WERE DISCONNECTED PRIOR TO SAVING THE REPORT WHICH RESULTED IN THE SYSTEM NOT RECORDING THE ACTUAL NEEDLE TYPES USED IN THE PROCEDURE. THE INVESTIGATION CONCLUDED THAT THE SYSTEM OPERATED AS DESIGNED.

    Description of Event or Problem · 1

    ON JULY 9, 2015, GALIL MEDICAL RECEIVED A WRITTEN COMPLAINT REFERENCING A CRYOABLATION PROCEDURE THAT OCCURRED ON (B)(6) 2013, ALLEGING THAT GALIL MEDICAL'S "CRYOABLATION SYSTEM AND/OR PROBES MALFUNCTIONED DURING THE PROCEDURE AND AS A RESULT THE PROCEDURE WAS UNSUCCESSFUL." FURTHER, "(THE PHYSICIAN'S) NOTES STATE 'THE CRYOABLATION PROBES HAD A SUBOPTIMAL FREEZE PATTERN WITH LIMITED MARGINS.'" REGARDING THE STATUS OF THE PATIENT, THE COMPLAINT STATES THAT THE "RENAL CELL CANCER RECURRED AND (THE PHYSICIAN) PERFORMED A SECOND CRYOABLATION PROCEDURE ON (B)(6) 2014. (THE PHYSICIANS) BELIEVE THIS SECOND PROCEDURE SUCCESSFULLY DESTROYED (THE PATIENT'S) RENAL CELL MASS. HOWEVER, IN THE MEANTIME, (THE PATIENT'S) RENAL CELL CANCER METASTASIZED TO HER LYMPH NODES AND LUNGS. (THE PATIENT) CURRENTLY SUFFERS FROM METASTATIC RENAL CELL CARCINOMA." ADDITIONALLY, THE COMPLAINT STATES THAT THE PATIENT BELIEVES THE DEVICES WERE MANUFACTURED BY GALIL MEDICAL, BUT THAT THEY ARE NOT ABSOLUTE CERTAIN THE MANUFACTURER OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517721 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL DEVICE AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other