ICEROD NEEDLE

Description of Event or Problem

IT WAS REPORTED VIA LITERATURE THAT PATIENTS EXPERIENCED PROCEDURE-RELATED COMPLICATIONS AS A RESULT OF CRYOABLATION PROCEDURES. THIS RETROSPECTIVE ANALYSIS INCLUDED 60 PATIENTS (60 PULMONARY NODULES) UNDERGOING CT(COMPUTED TOMOGRAPHY)-GUIDED BIOPSY-CRYOABLATION BETWEEN FEBRUARY 2023 AND OCTOBER 2023. 32 PATIENTS WERE INCLUDED IN THE BIOPSY-FIRST COHORT AND 28 PATIENTS WERE INCLUDED IN THE ABLATION-FIRST COHORT. SYNCHRONOUS BIOPSY-CRYOABLATION WAS PERFORMED UNDER CT GUIDANCE USING THE FPRCH600 SYSTEM (GALIL MEDICAL, ISRAEL) WITH 17G ICE ROD PLUS CRYOPROBES (1.5-MM DIAMETER) AND A 20G FINE BIOPSY NEEDLE (GALLINI S.R.L, ITALY). THE OVERALL RATE OF PROCEDURE-RELATED COMPLICATIONS WAS 78.1% (25/32) IN THE BIOPSY-FIRST COHORT VERSUS 53.6% (15/28) IN THE ABLATION-FIRST COHORT. THE RATE OF INTRAOPERATIVE HEMORRHAGE WAS 40.6% (13/32) IN THE BIOPSY-FIRST COHORT VERSUS 10.7% (3/28) IN THE ABLATION-FIRST COHORT (P=0.030). THE RATE OF CLINICALLY SIGNIFICANT (I.E. REQUIRING INTERVENTION) INTRA-OPERATIVE HEMORRHAGE WAS 31.3% (10/32) IN THE BIOPSY-FIRST COHORT VS 7.1% (2/28) IN THE ABLATION-FIRST COHORT. THE RATE OF PNEUMOTHORAX DID NOT DIFFER BETWEEN THE TWO COHORTS (40.6% VS 35.7%). NO SEVERE COMPLICATIONS OCCURRED IN EITHER COHORT. THE FOLLOWING ADDITIONAL PROCEDURE-RELATED COMPLICATIONS WERE REPORTED AT THE FOLLOWING OCCURRENCE RATES: PLEURAL EFFUSION: 4/28 (14.3%) IN ABLATION-FIRST, 6/32 (18.8%) IN BIOPSY-FIRST. CHEST PAIN: 5/28 (17.9%) IN ABLATION-FIRST, 8/32 (25%) IN BIOPSY-FIRST. FEVER: 3/28 (10.7%) IN ABLATION-FIRST, 6/32 (18.8%) IN BIOPSY-FIRST. PNEUMOTHORAX REQUIRING CHEST TUBE DRAINAGE: 3/28 (10.7%) IN ABLATION-FIRST, 3/32 (9.4%) IN BIOPSY-FIRST. PULMONARY INFECTION: 1/28 (2.6%) IN ABLATION-FIRST, 2/32 (6.3%) IN BIOPSY-FIRST.

Additional Manufacturer Narrative

A2 - AGE AT TIME OF EVENT: THE MEAN AGE AT THE TIME OF TREATMENT WAS 66.4 YEARS IN THE BIOPSY-FIRST COHORT, AND 66.9 YEARS IN THE ABLATION-FIRST COHORT. A3A - SEX: THE PERCENTAGE OF FEMALES IN THE BIOPSY-FIRST COHORT WAS 46.9% AND 42.9% IN THE ABLATION-FIRST COHORT. B3 - DATE OF EVENT: THE EVENT DATE WAS ESTIMATED TO THE EARLIEST KNOWN PROCEDURE INCLUDED IN THE STUDY. D3 - MANUFACTURER ADDRESS 1: TAVOR BUILDING 1, INDUSTRIAL PARK E1 - INITIAL REPORTER FACILITY NAME: (B)(6). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LAI, L., XU, F., AND TU, J. (2025). ABLATION-FIRST VERSUS BIOPSY-FIRST STRATEGY IN COMPUTED TOMOGRAPHY (CT)-GUIDED BIOPSY-CRYOABLATION FOR PULMONARY NODULES: A RETROSPECTIVE COHORT STUDY. CLINICAL RADIOLOGY, 97, 107223. HTTPS://DOI.ORG/10.1016/J.CRAD.2025.107223.