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	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost was observed on the needle shaft.Two iceseed 90 degree needles were selected for use in a cryoneurolysis procedure.During the procedure, frost formed on the shaft and handle of one of the needles.The physician believed that ice was supposed to form, so replaced the needle without frost with a new iceseed needle of a different lot; however, that replacement needle also had frost that formed on the needle shaft.The staff used protective measures on the skin where the frost on the needle met the skin, and there were no patient complications reported.
Additional Manufacturer Narrative
D3, g1 mfr site zip/post code: (b)(6).E1 initial reporter zip/post code: (b)(6).Evaluation of media: this iceseed 90 degree needle was disposed at the facility and not available for analysis; however, the physician provided a photo for review.Review of the photo confirmed frost on the shaft of the needle.

• 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 ; IS
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor bldg number 1; yokneam ; IS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17784724
• Report Number: 2124215-2023-51447
• Device Sequence Number: 12420562
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

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: 08/03/2025
• Device Model Number: FPRPR3202
• Device Catalogue Number: FPRPR3202
• Device Lot Number: 0029918140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown