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

Model Number	FPRPR3560
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost was observed on the needle shaft.This icesphere 90 degree needle was selected for use in a cryoablation procedure to treat renal cell carcinoma.During the procedure, frost formed on the shaft of the needle.Warm water was poured on the area where the needle meets the skin.The procedure was continued without sequalae.
Event or Problem Description
It was reported that frost was observed on the needle shaft.This icesphere 90 degree needle was selected for use in a cryoablation procedure to treat renal cell carcinoma.During the procedure, frost formed on the shaft of the needle.Warm water was poured on the area where the needle meets the skin.The procedure was continued without sequalae.
Additional Manufacturer Narrative
Device eval by manufacturer: the icesphere 1.5 90 degree needle from batch 29294464 was returned for analysis.Visual inspection of the exterior of the needle revealed no abnormalities.The needle was connected to the icefx console, and a two-minute confidence test was performed without any abnormal functionality.During the five-minute freeze cycle, the needle shaft became completely covered in frost.The needle was disassembled, and the vacuum sleeve was tested for vacuum integrity.The vacuum sleeve also became covered in frost, which indicates a defective vacuum sleeve.The vacuum sleeve was further inspected under a microscope revealing abnormalities in the metal that likely led to the vacuum integrity failing.

• Brand Name: ICESPHERE 90 DEGREE NEEDLE
• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16414614
• Report Number: 2124215-2023-08077
• Device Sequence Number: 19665046
• Product Code: GEH
• UDI-Device Identifier: 07290104830945
• UDI-Public: 07290104830945
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: 04/14/2024
• Device Model Number: FPRPR3560
• Device Catalogue Number: FPRPR3560
• Device Lot Number: 0029294464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown