MAUDE Adverse Event Report: BTG YOKNEAM ICEROD CX 90 DEGREE NEEDLE/VL; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3533
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost occurred on the needle shaft.A tissue cryotherapy procedure was performed using eight cryo needles.All the needles were placed in the tumor.During the freeze cycle, one of the eight needles experienced ice on the needle shaft.The other needles had no issue.To prevent a patient burn from the ice on the needle shaft, protective measures were performed immediately.The procedure was completed with the original devices.
Event or Problem Description
It was reported that frost occurred on the needle shaft.A tissue cryotherapy procedure was performed using eight cryo needles.All the needles were placed in the tumor.During the freeze cycle, one of the eight needles experienced ice on the needle shaft.The other needles had no issue.To prevent a patient burn from the ice on the needle shaft, protective measures were performed immediately.The procedure was completed with the original devices.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.Visual inspection of the exterior of the needle showed no abnormalities.The needle was connected to the icefx console, and a two-minute confidence test was performed without any abnormal functionality.A five-minute freeze cycle was performed, and it was found that the needle shaft became completely covered in frost.The needle was disassembled, and the vacuum sleeve was tested for vacuum integrity.The vacuum sleeve became covered in frost, meaning the vacuum sleeve was defective.The vacuum sleeve was inspected under a microscope for abnormalities.It was found that the vacuum sleeve had abnormalities in the metal that likely led to the vacuum insulation failing.

• Brand Name: ICEROD CX 90 DEGREE NEEDLE/VL
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial 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: 16728284
• Report Number: 2124215-2023-16361
• Device Sequence Number: 12411480
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121251
• 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): 09/27/2023

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 Expiration Date: 06/25/2024
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0029752958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown