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

Model Number	FPRPR3602
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Insufficient Heating (1287)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that 2 of the 4 iceforce needles had ithaw malfunctions; however, it was not specified which two.Therefore, the insufficient heating device code has been applied to batches 29784381, 29933256, 29734572, and 30125796.
Event or Problem Description
It was reported that there was frost on the needle shafts causing first degree burns.Four iceforce 2.1 cx 90 degree needles were selected for a cryoablation procedure to treat a rectal mass.During the initial freeze, the second probe had an ithaw malfunction.Then, during the second freeze, all four of the iceforce needles experienced insulation failures and frost appeared on the shafts.At this point, the third probe also had an ithaw malfunction.It was attempted to switch the gas tanks.Warm saline and saline bags were applied to protect the patient skin.First degree burns were still evident despite these efforts.Probes 2 and 3 were passively thawed while probes 1 and 4 were actively thawed, and all four probes were removed.The procedure was successfully completed, though it was cut a little short.The patient's frost bite was treated with a triple antibiotic after the procedure.The patient was stable.

• 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 building number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16373527
• Report Number: 2124215-2023-05376
• Device Sequence Number: 6814380
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: 07290104831003
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/14/2023

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: 07/18/2024
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: 0029784381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female