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	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was frost observed on one of the needles.This iceseed 90-degree needle was selected for a cryoablation procedure to treat an osteoma ostoide on the right femur on a young and thin patient.A needle test was performed for two minutes without any issues.Prior to the cryo ablation treatment, the physician performed a bone biopsy and had to reposition the needles many times.During the procedure, scans were performed (1min, 4min, 6min, and 8min) to watch the needle and hemorrhage surveillance.The skin remained well-colored albeit cold, so skin friction was created by the technicians during the "all-cryo" phase to activate blood circulation.A solid iceball was able to be felt under the skin, and frost was observed on the shaft of the iceseed needle so warm sterile gel was applied to the skin.At 8 min into treatment, the cryo therapy was decreased to 40% to help reduce the iceball formation.Passive thaw was then allowed at 5 min, and the iceball dissolved under the skin.Another scan was performed prior to starting the second phase of treatment, and treatment was only performed at 70% for 5 minutes and then 40% for the remaining 5 minutes.Again, skin friction was performed during the whole 10-minute treatment.At the end of the procedure, no skin discoloration was observed albeit the skin remained cold.Follow-up was performed to the physician; however, no patient complications were reported.

• 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): BOSTON SCIENTIFIC CORPORATION; tavor bldg number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15795104
• Report Number: 2124215-2022-46359
• Device Sequence Number: 11959745
• 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
• Report Date (Section B): 11/14/2022

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: 01/16/2025
• Device Model Number: FPRPR3202
• Device Catalogue Number: FPRPR3202
• Device Lot Number: 0029047178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown