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	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost occurred on the shaft.An icepearl 2.1 cx 90 degree needle was selected for a lung ablation.During preparation frost was noted on the needle shaft.The procedure was not completed due to an unrelated reason.There were no patient consequences as a result of this event.
Event or Problem Description
It was reported that frost occurred on the shaft.An icepearl 2.1 cx 90 degree needle was selected for a lung ablation.During preparation frost was noted on the needle shaft.The procedure was not completed due to an unrelated reason.There were no patient consequences as a result of this event.
Additional Manufacturer Narrative
Investigation results: 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 risk review performed for the icepearl 2.1 cx 90 degree needle device confirmed that the reported events are known events defined in the product's risk management documentation.These event types have 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; 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50157207
• Report Number: 2124215-2026-42128
• Device Sequence Number: 15788097
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: (01)07290104830563(17)280126(10)38442459
• 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,Followup
• Report Date (Section B): 09/08/2026

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: 0038442459
• 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: 07/13/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 01/26/2026
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 154 LB