MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost formed on the needle shaft.An icesphere 1.5 cx 90 degree needle was selected for a cryoablation procedure to treat a soft tissue mass in the lung.During the procedure, however, frost was forming on the needle shaft.To prevent frostbite, the needle was replaced with another needle of the same model.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: an icesphere 1.5 cx 90 degree 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, and it was discovered during this test that the device had frost on the shaft.The needle was disassembled and evaluated under a microscope for abnormalities.It was noted that there were abnormalities in the vacuum insulation tubing.The tubing showed some discoloration on the tubing.The vacuum insulation tubing was connected to a needle fixture and ran to verify the frost.The frost on the shaft was confirmed.
Event or Problem Description
It was reported that frost formed on the needle shaft.An icesphere 1.5 cx 90 degree needle was selected for a cryoablation procedure to treat a soft tissue mass in the lung.During the procedure, however, frost was forming on the needle shaft.To prevent frostbite, the needle was replaced with another needle of the same model.There were no patient complications reported.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• 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; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18160745
• Report Number: 2124215-2023-64372
• Device Sequence Number: 7215482
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/03/2024

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: 07/21/2024
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0029872522
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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 Age: 50 YR
• Patient Sex: Female