MAUDE Adverse Event Report: BTG YOKNEAM ICEROD PLUS 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3508
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure a leak occurred.An icerod plus 90 degree needle was selected for a cryoablation procedure to treat a malignant tumor located in the liver.During the testing phase prior to the procedure, a leak was observed from the icerod plus 90 degree needle.The icerod plus 90 degree needle was not used, and a different device of the same model was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported the procedure a leak occurred.An icerod plus 90 degree needle was selected for a cryoablation procedure to treat a malignant tumor located in the liver.During the testing phase prior to the procedure, a leak was observed from the icerod plus 90 degree needle.The icerod plus 90 degree needle was not used, and a different device of the same model was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.D3: manufacturer address 1: tavor building 1, industrial park.Device technical analysis: an icerod plus 90 degree needle was returned to arden hills cis for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were noticed.The needle was connected to the icefx console, and a two-minute confidence test was performed.No gas leak was observed from any part of the device, and the device sounded normal.A five-minute freeze was performed and there were no abnormalities in ice ball formation.The reported event of a gas leak was not confirmed.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the icerod plus 90 degree needle device confirmed that the reported event is a known event defined in the project risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 'device problem excluded' because there were no visual or functional abnormalities during testing, and no gas leak was observed anywhere on the device.The reported event was not confirmed.

• Brand Name: ICEROD PLUS 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; po box 224; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1, yokne; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 23755071
• Report Number: 2124215-2025-89667
• Device Sequence Number: 9521241
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: (01)07290104830563(17)260609(10)34252108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2026
• Device Model Number: FPRPR3508
• Device Catalogue Number: FPRPR3508
• Device Lot Number: 0034252108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 68 KG