MAUDE Adverse Event Report: BTG Yokneam Icerod Plus 90 Degree Needle; Unit, Cryosurgical, Accessories

Model Number	FPRPR3508
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was frost on the needle shaft.An icerod plus 90 degree needle was selected for use in a cryoablation procedure.During the procedure, it was observed that the entire needle shaft was covered in frost.The procedure was immediately halted; the needle was warmed and removed.The patient suffered mild frostbite on the skin, which was treated with warm water compresses.This was a first-degree burn.The cryoablation needle was replaced with another of the same to complete the procedure.It was noted that patient treatment was delayed as a result of this event.
Event or Problem Description
It was reported that there was frost on the needle shaft.An icerod plus 90 degree needle was selected for use in a cryoablation procedure.During the procedure, it was observed that the entire needle shaft was covered in frost.The procedure was immediately halted; the needle was warmed and removed.The patient suffered mild frostbite on the skin, which was treated with warm water compresses.This was a first-degree burn.The cryoablation needle was replaced with another of the same to complete the procedure.It was noted that patient treatment was delayed as a result of this event.
Additional Manufacturer Narrative
Initial reporter address 2: (b)(6).
Additional Manufacturer Narrative
Initial reporter address 2: (b)(6).Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, but the device has not been returned.Device history record review: the device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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 risk review was completed and confirmed that the event was defined in the risk 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 cause traced to component failure.

• Brand Name: Icerod Plus 90 Degree Needle
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG Yokneam; tavor building 1; industrial park po box 224; yokneam, 20692 03; IS 2069203
• Manufacturer (Section G): BTG Yokneam; tavor building number 1; 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: 50553607
• Report Number: 2124215-2026-46364
• Device Sequence Number: 10266010
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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 Model Number: FPRPR3508
• Device Catalogue Number: FPRPR3508
• Device Lot Number: 0038895813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 03/24/2026
• 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
• Patient Age: 74 YR
• Patient Sex: Female