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	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost appeared on the needle shaft.An icesphere 90 degree needle was selected for use in a cryoablation procedure in the kidney.During the procedure, the physician punctured the needle into the tumor, and after the freezing started, a thin layer of frost began to form on one needle.There was no frost on the other needle.The event occurred after the initial 10-minute freezing, a 10-minute spontaneous thawing, and a second 5-minute freezing.For the needle with frost, the physician started dripping warm water.Although frost was present on one needle, the freezing treatment was continued while performing the warm water drop procedure.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Initial reporter address (b)(6).
Event or Problem Description
It was reported that frost appeared on the needle shaft.An icesphere 90 degree needle was selected for use in a cryoablation procedure in the kidney.During the procedure, the physician punctured the needle into the tumor, and after the freezing started, a thin layer of frost began to form on one needle.There was no frost on the other needle.The event occurred after the initial 10-minute freezing, a 10-minute spontaneous thawing, and a second 5-minute freezing.For the needle with frost, the physician started dripping warm water.Although frost was present on one needle, the freezing treatment was continued while performing the warm water drop procedure.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) university of medicine.Initial reporter address 1: (b)(6).Device eval by manufacturer: the returned device was hooked up to the in-house console and functional testing was performed.A 5-minute freeze cycle was performed, and frost on the shaft appeared almost instantly.The shaft temperature on the needle reached -37 degrees celsius, pointing to insufficient thermal insulation of the needle.The device was disassembled, and the vacuum insulation sleeve was tested.Frost formed on the entirety of the vacuum insulation sleeve.Microscopic analysis found damage to the insulation tube.

• Brand Name: ICESPHERE 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavorbuilding1,industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL ISRAEL; tavor bldg 1; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15650068
• Report Number: 2124215-2022-42485
• Device Sequence Number: 6094332
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 04/03/2023
• Device Model Number: FPRPR3560
• Device Catalogue Number: FPRPR3560
• Device Lot Number: U2704
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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