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

Model Number	FPRPR3533
Medical Device Problem Codes	Insufficient Cooling (1130); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an air/gas leak occurred at the shaft of the device.An iceforce cx 90 degree needle was selected for a desmoid cryoablation.During preparation, bubbles were noted from the shaft of the device while insufficient ice occurred.The needle was fully submerged during the integrity testing.There were no patient complications, and the case was completed with a different device of the same model.
Additional Manufacturer Narrative
H11: device evaluation by manufacturer: analysis: an icerod cx 90 degree needle/vl (34257562) was returned to arden hills cis for analysis.Visual inspection of the exterior of the needle was performed, and no abnormalities were noted.The needle was connected to the icefx console, and a two-minute confidence test was performed.The test performed normally.A five-minute freeze in gel was performed to analyze ice ball formation.It was noted that the ice ball formation looked normal and resulted in an ice ball that measured approximately 19 mm x 42.5 mm, which is within specification for the icerod cx 90 degree needle/vl.The device passed the two-minute confidence test, produced an ice ball of sufficient size.
Event or Problem Description
It was reported that an air/gas leak occurred at the shaft of the device.An iceforce cx 90 degree needle was selected for a desmoid cryoablation.During preparation, bubbles were noted from the shaft of the device while insufficient ice occurred.The needle was fully submerged during the integrity testing.There were no patient complications, and the case was completed with a different device of the same model.

• 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: 20922251
• Report Number: 2124215-2024-78294
• Device Sequence Number: 15525289
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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 Expiration Date: 06/18/2026
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0034257562
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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
• Patient Sex: Unknown