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

Model Number	FPRPR3202
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported frost on the needle shaft occurred.An iceseed 90 degree needle was used during cryoablation of a tibial osteoid osteoma.Four minutes into the first freeze cycle, frost was observed on the shaft of the needle near the patients' skin.The skin was getting very cold even with the use of a warm saline bag as protection.The freezing phase was stopped and a computed tomography (ct) scan found no abnormal air, and the ice ball could be visualized in the muscle.Passive thaw was used, then when the patients' skin was warm, another freezing cycle was attempted but was stopped after two minutes because frost on the shaft occurred again.The needle was removed from the patient and tested again in a tray of water, no leaks, abnormal formation of ice, no frost or unusual ice was observed on the shaft.The needle was placed in the patient again and a freeze cycle was started, frost on the shaft after one minute, freeze cycle was stopped.The physician then exchanged the iceseed needle for an icesphere needle used at 50% to complete treatment because no other iceseed needle was available on site.Treatment was completed successfully with no complications post-treatment.
Additional Manufacturer Narrative
Device/media analysis: the returned device was visually inspected; there was no obvious damage or issues with the needle.The device was ran on an in-house console and produced an iceball of the correct size.The frost on the shaft was observed and did not appear to be more than expected for this needle.It was noted that this is an iceseed needle which does not have a vacuum insulation sleeve in the shaft of the needle; therefore, frost is to be expected on the shaft.Disassembly of the needle found no damage that could have contributed to the reported issue of excessive frost on the shaft.
Event or Problem Description
It was reported frost on the needle shaft occurred.An iceseed 90 degree needle was used during cryoablation of a tibial osteoid osteoma.Four minutes into the first freeze cycle, frost was observed on the shaft of the needle near the patients' skin.The skin was getting very cold even with the use of a warm saline bag as protection.The freezing phase was stopped and a computed tomography (ct) scan found no abnormal air, and the ice ball could be visualized in the muscle.Passive thaw was used, then when the patients' skin was warm, another freezing cycle was attempted but was stopped after two minutes because frost on the shaft occurred again.The needle was removed from the patient and tested again in a tray of water, no leaks, abnormal formation of ice, no frost or unusual ice was observed on the shaft.The needle was placed in the patient again and a freeze cycle was started, frost on the shaft after one minute, freeze cycle was stopped.The physician then exchanged the iceseed needle for an icesphere needle used at 50% to complete treatment because no other iceseed needle was available on site.Treatment was completed successfully with no complications post-treatment.

• Brand Name: ICESEED 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): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13652698
• Report Number: 2134265-2022-02274
• Device Sequence Number: 16736680
• Product Code: GEH
• UDI-Device Identifier: 07290104830235
• UDI-Public: 07290104830235
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003065
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 05/27/2024
• Device Model Number: FPRPR3202
• Device Catalogue Number: FPRPR3202
• Device Lot Number: U2925
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown