BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 14792603 · Received June 23, 2022

    Report

    Report Number
    2134265-2022-07184
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 23, 2023
    Manufacturer
    BTG ROUND LAKE
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRO CODE (PRODUCT CODE) - OCL.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE) - OCL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A CRYOABLATION CONSOLE AND SIX NEEDLES WERE SELECTED FOR THE TREATMENT OF A RENAL CELL CARCINOMA. TESTING WAS PERFORMED SUCCESSFULLY PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, SEVEN MINUTES INTO THE FREEZE CYCLE, IT WAS DETERMINED THAT ONE ICEFORCE 2.1 CX 90 DEGREE NEEDLE AND TWO ICEFORCE 2.1CX NEEDLES WERE NOT FREEZING. A SECOND CYCLE WAS PERFORMED WITH THE THREE NON-FUNCTIONING NEEDLES. A THIRD CYCLE WITH THE NON-FUNCTIONAL NEEDLES WAS PERFORMED WITH A FRESH CAN OF ARGON. AFTER THE THIRD ATTEMPT WITH THE NON-FUNCTIONAL NEEDLES, THE PHYSICIAN DETERMINED THAT THE TUMOR WAS LIKELY UNDERTREATED AND THE PATIENT WILL NEED TO RETURN FOR AN ADDITIONAL TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. A CRYOABLATION CONSOLE AND SIX NEEDLES WERE SELECTED FOR THE TREATMENT OF RENAL CELL CARCINOMA. DURING THE PROCEDURE, AT THE 7 MINUTE SCAN, IT WAS DETERMINED THAT ONE ICEFORCE 2.1 CX 90 DEGREE NEEDLE AND TWO ICEFORCE 2.1CX NEEDLES WERE NOT FREEZING. A SECOND CYCLE WAS PERFORMED WITH THE NON-FUNCTIONING NEEDLES. A THIRD CYCLE WITH THE NON-FUNCTIONAL NEEDLES WAS PERFORMED WITH A FRESH CAN OF ARGON. AFTER THE THIRD ATTEMPT WITH THE NON-FUNCTIONAL NEEDLES, THE PHYSICIAN DETERMINED THAT THE TUMOR WAS LIKELY UNDERTREATED AND THE PATIENT WILL NEED TO RETURN FOR AN ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401281 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH BTG ROUND LAKE FPRCH6000 VL0404 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown