MAUDE Adverse Event Report: BTG YOKNEAM ICEPEARL 2.1 CX 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3601
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced a skin burn.An icepearl 2.1 cx 90 degree needle was chosen for a renal cryoablation procedure to treat a renal cell carcinoma.The treatment was completed and the icepearl 2.1 cx 90 degree needle functioned as expected.During closure, a sterile towel was removed and revealed a burn of an unknown degree on the patient's skin.The physician stated that he had placed several wet sterile towels on top of the argon hose connected to the icepearl 2.1 cx 90 degree needle, and the argon hose froze through a sterile towel covering the patient's skin resulting in the burn.Frost on the cable of the device was observed.The procedure was completed with the original device.The patient was treated for the skin burn during recovery; however, the specific details of post-procedure treatment is unknown.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.D3: manufacturer address 1- tavor building 1, industrial park.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.D3: manufacturer address 1- tavor building 1, industrial park.E1 - initial reporter email: updated with additional information.
Event or Problem Description
It was reported the patient experienced a skin burn.An icepearl 2.1 cx 90 degree needle was chosen for a renal cryoablation procedure to treat a renal cell carcinoma.The treatment was completed and the icepearl 2.1 cx 90 degree needle functioned as expected.During closure, a sterile towel was removed and revealed a burn of an unknown degree on the patient's skin.The physician stated that he had placed several wet sterile towels on top of the argon hose connected to the icepearl 2.1 cx 90 degree needle, and the argon hose froze through a sterile towel covering the patient's skin resulting in the burn.Frost on the cable of the device was observed.The procedure was completed with the original device.The patient was treated for the skin burn during recovery; however, the specific details of post-procedure treatment is unknown.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE NEEDLE
• 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; yokneam 20692 03; IS 2069203
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 22681312
• Report Number: 2124215-2025-52777
• Device Sequence Number: 15676515
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: (01)07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K152133
• 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,Followup
• Report Date (Section B): 05/14/2026

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 Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female