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

Model Number	FPRPR3602
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a gas/air leak occurred on the shaft of the device.Three iceforce 2.1 cx 90 degree needles were chosen for a cryoablation procedure to treat a patient.During preparation prior to the procedure, an audible noise was heard from one of the iceforce 2.1 cx 90 degree needles.During the 2-minute testing period, bubbles were observed along the shaft of one of the iceforce 2.1 cx 90 degree needles.The one iceforce 2.1 cx 90 degree needle that experienced this device issue was discarded and not used inside of the patient.An alternate device of the same model was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported a gas/air leak occurred on the shaft of the device.Three iceforce 2.1 cx 90 degree needles were chosen for a cryoablation procedure to treat a patient.During preparation prior to the procedure, an audible noise was heard from one of the iceforce 2.1 cx 90 degree needles.During the 2-minute testing period, bubbles were observed along the shaft of one of the iceforce 2.1 cx 90 degree needles.The one iceforce 2.1 cx 90 degree needle that experienced this device issue was discarded and not used inside of the patient.An alternate device of the same model was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H11: device evaluation by manufacturer: the device was visually examined to reveal no initial abnormalities.Functional testing of the complaint device found no issues during the underwater pretest.There were no gas leaks found on any part of the returned device.

• Brand Name: ICEFORCE 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, ind park; 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: 22917837
• Report Number: 2124215-2025-60361
• Device Sequence Number: 13288595
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: (01)07290104831003(17)270511(10)36455963
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: 0036455963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ICEFORCE 2.1 CX 90 DEGREE NEEDLES; ICEFORCE 2.1 CX 90 DEGREE NEEDLES
• Patient Sex: Unknown