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

Model Number	FPRPR3602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient freeze burn occurred.An iceforce 2.1 cx 90 degree needle was selected for a cryoablation procedure to treat a desmoid tumor.During the freeze cycle, however, after four minutes of monitoring and an ultrasound scan, it was noticed that the frosted part of the tubing was contacting the patient skin.A sterile towel was placed between the tubing and the skin, and the procedure was continued.Saline was applied to the area throughout the procedure.The procedure was completed successfully with the original device.After the procedure, staff treated the affected area on the patient skin like a burn and draped and wrapped the arm.The patient was expected to fully recover.

• Brand Name: ICEFORCE 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): BOSTON SCIENTIFIC CORPORATION; tavor bldg number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17038797
• Report Number: 2124215-2023-26274
• Device Sequence Number: 6515902
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: 07290104831003
• 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
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2024
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: 0029805708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Female