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	Burn(s) (1757)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that frost on the needle shafts occurred, resulting in minor patient burns that required treatment with antibiotics.Seven iceforce 2.1 cx 90 degree needles were selected for a cryoablation procedure to treat renal cell cancer in the kidney.Each of the probes tested fine and an initial 10-minute freeze was completed.During the second freeze, however, the temperature began to rise on each of the probes along with the gas firing intermittently.The gas tanks were replaced several times until normal freezing resumed to complete the procedure.During this time, it was noted that three of the seven probes had frost on the needle shafts.Warm saline bags were used to heat the areas of the skin that were in contact with the frost.The probes were used to complete the procedure.An ithaw malfunction also occurred with all of the needles, so the second thaw was completed passively.The patient experienced minor burns from frostbite, which were treated with antibiotics and home care following the procedure.The patient was expected to fully recover.
Additional Manufacturer Narrative
Manufacturer address (b)(4).
Event or Problem Description
It was reported that frost on the needle shafts occurred, resulting in minor patient burns that required treatment with antibiotics.Seven iceforce 2.1 cx 90 degree needles were selected for a cryoablation procedure to treat renal cell cancer in the kidney.Each of the probes tested fine and an initial 10-minute freeze was completed.During the second freeze, however, the temperature began to rise on each of the probes along with the gas firing intermittently.The gas tanks were replaced several times until normal freezing resumed to complete the procedure.During this time, it was noted that three of the seven probes had frost on the needle shafts.Warm saline bags were used to heat the areas of the skin that were in contact with the frost.The probes were used to complete the procedure.An ithaw malfunction also occurred with all of the needles, so the second thaw was completed passively.The patient experienced minor burns from frostbite, which were treated with antibiotics and home care following the procedure.The patient was expected to fully recover.
Additional Manufacturer Narrative
Manufacturer address 1: (b)(4).Device evaluated by manufacturer: the needles were returned with all the needles bundled together in one bag and the cables cut.Individual needle lots were unable to be confirmed or linked to specific needles.Functional testing was unable to be performed as the cables were cut.The needle was disassembled to test the insulation tube.The insulation tube was found to have been collapsed along its length.It is unclear what caused the collapse.The collapse appears to be the cause of the reported frost on shaft.The ithaw heater was inspected and there was no obvious damage to the heater.It is unknown if the reported ithaw error was due to inconsistent gas pressure in the system or if the collapsed tube damaged the wires inside.

• Brand Name: ICEFORCE 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1, yokne; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15730498
• Report Number: 2124215-2022-43199
• Device Sequence Number: 2919673
• 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,Followup
• Report Date (Section B): 12/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2024
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: 0029657380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG