BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIT, CRYOSURGICAL, ACCESSORIES

    MDR report key: 10093833 · Received May 27, 2020

    Report

    Report Number
    2134265-2020-06972
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BTG YOKNEAM
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAYE, D., MORALES-RIVERA, S., GLAZER, D., TUNCALI, K., LEVESQUE, V., & SHYN, P. (2020). ABSTRACT NO. 500 CRYOPROBE FACTORS ASSOCIATED WITH HIGHER COMPLICATION RATES IN PATIENTS UNDERGOING PERCUTANEOUS IMAGE-GUIDED LIVER TUMOR CRYOABLATION. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 31(3), S220. HTTPS://DOI.ORG/10.1016/J.JVIR.2019.12.561.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ABSTRACT NO. 500 "CRYOPROBE FACTORS ASSOCIATED WITH HIGHER COMPLICATION RATES IN PATIENTS UNDERGOING PERCUTANEOUS IMAGE-GUIDED LIVER TUMOR CRYOABLATION". THE PURPOSE OF THE STUDY WAS TO EVALUATE POSSIBLE ASSOCIATIONS BETWEEN CRYOABLATION PROBE FACTORS AND HIGH-GRADE ADVERSE EVENTS (AE) IN PATIENTS UNDERGOING PERCUTANEOUS IMAGE-GUIDED HEPATIC TUMOR CRYOABLATION. THE STANDARD CRYOABLATION PROTOCOL UTILIZED THE SEEDNET SYSTEM (GALIL MEDICAL, INC) AND INCLUDED TWO 15-MINUTE FREEZE APPLICATIONS SEPARATED BY A 10-MINUTE THAW. PROCEDURE RELATED AE WERE GRADED USING THE CTCAE GRADING SYSTEM. HIGH GRADE POSTPROCEDURAL AE WERE DEFINED AS CTCAE GRADES 3 OR HIGHER. A TOTAL OF 204 PATIENTS MET INCLUSION CRITERIA (52% FEMALE, AGE RANGE 29 TO 91, MEAN 62.4). AVERAGE TUMOR DIAMETER WAS 0.4-5 CM. 25% OF TUMORS WERE PRIMARY HEPATIC MALIGNANCIES WITH THE REMAINING CONSISTING OF METASTATIC HEPATIC LESIONS. INSULATED PROBES WERE USED IN 50% OF THE CASES. WE OBSERVED AN OVERALL 28% AE RATE DURING THE STUDY PERIOD, THE HIGH-GRADE AE RATE WAS 6%. THERE WERE A TOTAL OF 8 GRADE 3 AND 3 GRADE 4 AE. NO GRADE 5 AE OCCURRED. ONE OF THE AUTHORS OF THE ARTICLE STATED "WE ARE ACTUALLY ADDING MORE DATA TO THIS STUDY AND WILL HOPEFULLY BE PUBLISHING IT SOON, IN WHICH THE FULL AE DATA WILL BE LISTED. PROBABLY IN A FEW MONTHS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558427 UNIT, CRYOSURGICAL, ACCESSORIES GEH BTG YOKNEAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention