MAUDE Adverse Event Report: BTG YOKNEAM Icerod Needle; Unit, Cryosurgical, Accessories

Model Number	FPRPR3203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hemoptysis (1887); Hemothorax (1896); Pain (1994); Pleural Effusion (2010); Pneumothorax (2012); Unspecified Gastrointestinal Problem (4491)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event- publish date selected.Detailed product information was not provided to bsc.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.Yao, p., ye, x., wang, m., liu, c., tao, x., hu, h., & wu, x.(2025).Safety and efficacy of microwave ablation versus argon-helium cryoablation for the treatment of primary high-risk pulmonary nodules: a propensity score-matched study.Quantitative imaging in medicine and surgery, 15(12), 12765-12776.Https://doi.Org/10.21037/qims-2025-1673.
Event or Problem Description
It was reported that adverse events occurred, and catheterization was required.This retrospective analysis aimed to compare the safety and efficacy of microwave ablation (mwa) versus cryoablation (ca) in patients with primary high-risk pulmonary nodules.All lung mwa and ca procedures were performed by two experienced (>5 years) interventional radiologists under computed tomography (ct) guidance.General anesthesia was administered through a combination of intravenous and inhalational agents.Continuous monitoring of cardiac activity and vital parameters was maintained throughout each procedure.Upon completion, a follow-up ct scan was performed to detect any immediate complications, and patients were subsequently transferred to an inpatient unit for observation.Cryoablation was performed using visual ice? system with icerod1.5 cryoprobes under ct guidance to ensure the targeted nodule was encompassed by an adequate margin.The ablation protocol consisted of three freeze-thaw cycles.The protocol included a first freeze of 3 minutes, a thaw period of 3 minutes, a second freeze lasting 8 minutes, followed by a 5-minute thaw, and a final 8-minute freeze before active thawing.The ablation zone was assessed with non-contrast ct imaging at 3-5-minute intervals during the procedure to confirm ice coverage with at least a 5 mm circumferential margin beyond the tumor.After ablation, patients underwent outpatient follow-up with ct imaging scheduled at 1, 3, and 6 months, and then at six-month intervals thereafter.The primary endpoints assessed in this study included technical success, clinical efficacy, safety profile, disease-free survival (dfs), and overall survival (os).A total of 31 patients with 35 primary high-risk pulmonary nodules treated by ca were included in the analysis.The complication rates were comparable between the two groups: ca, 25/31 versus mwa, 68/108.The most common complications were pneumothorax (50.36%) and pleural effusion (30.22%).No ablation-related deaths occurred.Mild pneumothorax was observed in 14 of the patients and moderate to severe pneumothorax occurred in 3 patients from the ca group.Mild pleural effusion was observed in 10 patients from the ca group.Hemothorax was also noted in 1 patient, subcutaneous emphysema in 3 patients, hemoptysis in 3 patients, catheterization in 4 patients and fever within 48 hours postoperatively in 3 patients from the ca group.The pain scores of the ca group were significantly lower than those of the mwa group.The median hospital stay was 5 days in the ca group.

• Brand Name: Icerod Needle
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG YOKNEAM; tavor building 1; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): Galil Medical Ltd.; tavor bldg. 1; industrial park; yokneam 20692 03; IS 2069203
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25894295
• Report Number: 2124215-2026-39269
• Device Sequence Number: 13253693
• Product Code: GEH
• UDI-Device Identifier: 07290104830198
• UDI-Public: (01)07290104830198
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FPRPR3203
• Device Catalogue Number: FPRPR3203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 08/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown