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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft frost occurred.An icerod plus 90 degree needle was selected for use.During device preparation, the needle frosted up the shaft.The needle was exchanged and the procedure was completed.There were no patient consequences as a result of this event.
Additional Manufacturer Narrative
D3/g1: 2069203 investigation results: device history record (dhr) 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.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; yokneam ; IS
• Manufacturer (Section G): Boston Scientific Corporation; tavor building 1; industrial park; yokneam ; IS
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50419161
• Report Number: 2124215-2026-45419
• Device Sequence Number: 18669635
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: (01)07290104830563(17)280322(10)38908211
• 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): 08/24/2026

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: 0038908211
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 03/23/2026
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 158 LB