MAUDE Adverse Event Report: BTG YOKNEAM ICEPEARL 2.1 CX 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3601
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was needle shaft frost.An icepearl 2.1 cx 90 degree needle was selected for a cryoablation procedure in the lung.There was approximately 5cm of the needle shaft outside the skin.Within 20-30 seconds of the initial freeze, the needle shaft frosted over and there was frost on the skin.Warm saline was used around the skin.Three freeze cycles were completed.At the end of the procedure the needle was able to fast thaw but was not able to come to temperature or complete the cautery function.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned for analysis.The atp testing and the shaft temperature below the spec suggest a compromised thermal insulation vacuum sleeve.The ice ball size was unable to be recognized during atp testing due to the shaft being covered with frost.The vacuum sleeve external surface was found to have soldering flux and tin residuals.No leak was found on the vacuum sleeve external surface.A visual inspection of the heater wires was done after needle disassemble.No damage to the wire insulation on the heater wire was found.
Event or Problem Description
It was reported there was needle shaft frost.An icepearl 2.1 cx 90 degree needle was selected for a cryoablation procedure in the lung.There was approximately 5cm of the needle shaft outside the skin.Within 20-30 seconds of the initial freeze, the needle shaft frosted over and there was frost on the skin.Warm saline was used around the skin.Three freeze cycles were completed.At the end of the procedure the needle was able to fast thaw but was not able to come to temperature or complete the cautery function.There were no patient complications.

• Brand Name: ICEPEARL 2.1 CX 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 GALIL MEDICAL; 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: 12721328
• Report Number: 2134265-2021-13439
• Device Sequence Number: 3855480
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152133
• 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): 01/11/2022

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: 02/27/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U2320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown