MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer address 1: tavor building 1, industrial park.
Event or Problem Description
It was reported that the patient experienced a skin burn.Three icesphere 1.5 cx 90 degree needles were chosen for a geniculate nerve cryoablation procedure.The treatment was completed and all three icesphere 1.5 cx 90 degree needles functioned as expected.During follow-up, a burn of an unknown degree was discovered on the patient's skin.The physician treated the skin burn with healing ointment and an oral medicine.The patient is expected to full recover without permanent impairment.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; 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 ; 6512422111
• MDR Report Key: 23067408
• Report Number: 2124215-2025-64783
• Device Sequence Number: 15915190
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: (01)07290104831133(17)260725(10)34506744
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 Expiration Date: 07/25/2026
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0034506744
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Date Device Manufactured: 07/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICESPHERE 1.5 CX 90 DEGREE NEEDLE LOT# 34506744; ICESPHERE 1.5 CX 90 DEGREE NEEDLE LOT# 36078487
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown