BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICESEED NEEDLE

    MDR report key: 24152247 · Received January 22, 2026

    Report

    Report Number
    2124215-2026-04128
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    September 1, 2018
    Report Date
    January 22, 2026
    Manufacturer
    BTG YOKNEAM
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED TO BE THE FIRST DATE OF THE RANGE SEPTEMBER 2018 TO NOVEMBER 2023 D3: MANUFACTURER ADDRESS 1: TAVOR BUILDING 1, INDUSTRIAL PARK. FISH, A., KNIGHT, E., & MADOFF, D. (2024). CRYOABLATION OF LUNG TUMORS IN PATIENTS WITH STEREOTACTIC BODY RADIATION THERAPY RECURRENCE [ABSTRACT]. ECIO 2024 - ABSTRACT BOOK, EUROPEAN CONFERENCE ON INTERVENTIONAL ONCOLOGY, S21.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT PATIENTS TREATED WITH CRYOABLATION EXPERIENCED PNEUMOTHORAX AND HOSPITALIZATION. THIS RETROSPECTIVE ANALYSIS AIMED TO EVALUATE THE SAFETY AND EFFICACY OF LUNG TUMOR CRYOABLATION IN PATIENTS WITH STEREOTACTIC BODY RADIATION THERAPY (SBRT) RECURRENCE. BETWEEN SEPTEMBER 2018 AND NOVEMBER 2023, 38 PATIENTS WITH RECURRENCE OF LUNG TUMORS AFTER SBRT (28 NON-SMALL CELL LUNG CANCER AND 9 METASTATIC DISEASE) WERE CRYOABLATED WITH 45 TREATMENT SESSIONS USING THE VISUAL ICE CRYOABLATION SYSTEM. RESULTS SHOWED THAT PNEUMOTHORAX AND HOSPITALIZATION RATES WERE 42.2% (19/45) AND 35.6% (16/45).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212041 ICESEED NEEDLE UNIT, CRYOSURGICAL, ACCESSORIES GEH BTG YOKNEAM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O