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

Model Number	FPRPR3604
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Insufficient Cooling (1130)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported frost occurred on the device and the patient experienced a skin burn.Two cryoablation needles were chosen for the cryoablation treatment of a renal tumor located in the right kidney.Under computed tomography (ct) imaging, the correct placement of the needles was confirmed.The freeze began, but about halfway through the first freeze, the machine stopped freezing intermittently.They stopped the freeze cycle and took the needles out of the machine and then attempted to plug them back in to see if it would resolve the issue.However, the needles would not go back into the previous slots.The needles were repositioned in new slots, and the freeze cycle was started again.During the freeze, it was noticed that the needles were not giving a temperature reading.When the needles were observed for any ice formation, it was noted that one of them did not look right.The machine was shut off immediately.When examining the patient, the skin was white and cold to the touch.The skin around the needle was warmed up by placing a hand over the skin.They waited about 20 minutes and then the physician took the 2 cryoablation needles out of the kidney.They did a follow up ct scan with contrast dye.No further complications have been reported.
Additional Manufacturer Narrative
D3: manufacturer address 1- tavor building 1, industrial park.
Additional Manufacturer Narrative
B3: event date updated.D3: manufacturer address 1- tavor building 1, industrial park.H10: related report number added.
Event or Problem Description
It was reported frost occurred on the device and the patient experienced a skin burn.Two cryoablation needles were chosen for the cryoablation treatment of a renal tumor located in the right kidney.Under computed tomography (ct) imaging, the correct placement of the needles was confirmed.The freeze began, but about halfway through the first freeze, the machine stopped freezing intermittently.They stopped the freeze cycle and took the needles out of the machine and then attempted to plug them back in to see if it would resolve the issue.However, the needles would not go back into the previous slots.The needles were repositioned in new slots, and the freeze cycle was started again.During the freeze, it was noticed that the needles were not giving a temperature reading.When the needles were observed for any ice formation, it was noted that one of them did not look right.The machine was shut off immediately.When examining the patient, the skin was white and cold to the touch.The skin around the needle was warmed up by placing a hand over the skin.They waited about 20 minutes and then the physician took the 2 cryoablation needles out of the kidney.They did a follow up ct scan with contrast dye.No further complications have been reported.

• Brand Name: ICEFORCE 2.1 CX NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; tavor building 1; industrial park; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20514143
• Report Number: 2124215-2024-64094
• Device Sequence Number: 9232364
• Product Code: GEH
• UDI-Device Identifier: 07290104831027
• UDI-Public: 07290104831027
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FPRPR3604
• Device Catalogue Number: FPRPR3604
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/15/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown