BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICESEED NEEDLE

    MDR report key: 22865548 · Received August 21, 2025

    Report

    Report Number
    2124215-2025-57533
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    January 1, 2012
    Report Date
    August 21, 2025
    Manufacturer
    BTG YOKNEAM
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT- EVENTS OCCURRED FROM 2012 TO 2017. ASANUMA, K., NAKATSUKA, A., NAKAMURA, T., FUJIMORI, M., YAMANAKA, T., HAGI, T., MATSUYAMA, Y., IINO, T., & HASEGAWA, M. (2024). CRYOABLATION FOR MALIGNANT BONE AND SOFT TISSUE TUMORS AND HISTOLOGICAL ASSESSMENT OF ABLATED TUMORS. ANTICANCER RESEARCH, 44, 5463-5476. HTTPS://DOI.ORG/10.21873/ANTICANRES.17372.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT INFECTION OCCURRED, REQUIRING INTERVENTION. TWENTY-SEVEN PATIENTS WHO UNDERWENT A TOTAL OF 55 SESSIONS OF PERCUTANEOUS CRYOABLATION FOR THE TREATMENT OF BONE AND SOFT TISSUE TUMORS BETWEEN 2012 AND 2017 AT MIE UNIVERSITY HOSPITAL WERE ENROLLED IN A RETROSPECTIVE STUDY. PATIENTS WERE FOLLOWED UP OR TREATED IN THE DEPARTMENT OF ORTHOPEDIC SURGERY FOR MALIGNANT TUMORS IN THE BONE OR SOFT TISSUE. ALL CRYOABLATION PROCEDURES WERE PERFORMED IN THE DEPARTMENT OF INTERVENTIONAL RADIOLOGY WITH THE AIM OF ACHIEVING LOCAL CONTROL. CRYOABLATION WAS PERFORMED USING CRYOHIT CRYOABLATION SYSTEM UNDER COMPUTED TOMOGRAPHY (CT)-FLUOROSCOPIC GUIDANCE. SEVENTEEN-GAUGE CRYOPROBES WERE PLACED INTO THE TUMOR ACCORDING TO THEIR SIZE AND SHAPE UNDER LOCAL ANESTHESIA WITH 1% LIDOCAINE. CT WAS PERFORMED TO EVALUATE THE ENTIRE TUMOR, WITH THE ICE BALL EXTENDING AT LEAST 5 MM BEYOND THE TUMOR MARGIN. TWO FREEZE-THAW CYCLES OF CRYOABLATION WERE PERFORMED. IF THE ICE BALL DID NOT SUFFICIENTLY COVER THE TUMOR MARGINS, AN ADDITIONAL CRYOPROBE WAS CONSIDERED FOR COMPLETE COVERAGE, DEPENDING ON TUMOR SIZE AND SHAPE. AFTER COMPLETION OF CRYOABLATION, NON-ENHANCED CT WAS PERFORMED TO SCREEN FOR IMMEDIATE COMPLICATIONS. OF THE (B)(4) PATIENTS, ONE PATIENT DEVELOPED AN INFECTION AT THE SITE OF CRYOABLATION AND UNDERWENT SURGICAL DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410493 ICESEED NEEDLE UNIT, CRYOSURGICAL, ACCESSORIES GEH BTG YOKNEAM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention