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

Model Number	FPRPR3602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3: manufacturer address 1- (b)(6).
Event or Problem Description
It was reported the patient experienced a skin burn.An iceforce 2.1 cx 90 degree needle was chosen for a cryoablation procedure to treat a site in the patient's kidney.The procedure occurred in a different room than the one used routinely for this type of procedure.In addition, the device was placed under ultrasound instead of computed tomography (ct), so a different size drape with a larger field was used that exposed more of the patient's skin.When the patient was moved to take a ct scan, it is likely that the cryoablation tubing laid against the patient's skin unexpectedly.Consequently, frostbite occurred on the patient's skin.The procedure was completed with the original device and the patient is expected to fully recover.
Additional Manufacturer Narrative
Correction to b2: outcomes attrib to adv event, b5: describe event or problem section, and h6: impact codes.Update to h6: evaluation conclusion codes and evaluation method codes based on additional information.D3: manufacturer address 1- tavor building 1, industrial park.Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the lot # is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the patient experienced a skin burn.An iceforce 2.1 cx 90 degree needle was chosen for a cryoablation procedure to treat a site in the patient's kidney.The procedure occurred in a different room than the one used routinely for this type of procedure.In addition, the device was placed under ultrasound instead of computed tomography (ct), so a different size drape with a larger field was used that exposed more of the patient's skin.When the patient was moved to take a ct scan, it is likely that the cryoablation tubing laid against the patient's skin unexpectedly.Consequently, frostbite occurred on the patient's skin.The procedure was completed with the original device and the patient is expected to fully recover.It was provided that the patient was given silva cream and antibiotics to treat the burn.

• Brand Name: ICEFORCE 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; yokneam ; IS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22045502
• Report Number: 2124215-2025-31971
• Device Sequence Number: 8990419
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: (01)07290104831003
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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 Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown