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 Codes	Burn(s) (1757); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost formed on the needle shaft.An iceforce 2.1 cx 90 degree needle was selected for a renal cryoablation procedure.Three additional needles were used for the procedure, and all tested fine.After each needle was placed in the renal tumor, the freeze began.All four needles started to freeze, and towels were placed under the tubing to prevent frostbite on the skin.An ithaw error appeared on the console for the needles in channel 1a and 4a.There was no temperature displayed, but argon could be heard moving through the console.Nine minutes into the first freeze, a scan was performed, and the ice ball was acceptable to the physician.The needles were moved during the passive thaw to another channel, and the second freeze was started.The needles still reported ithaw errors.It was noted that during the second freeze, the fellow had noticed that two of the needles had started to freeze along the shaft and were freezing the skin in a circular pattern at their entry site.The anesthesiologist used a big hose that blew hot air onto the needles and entry site for approximately 10 minutes before removing the needles.No significant burn was observed after the needles were removed.The patient was kept at the hospital overnight for observation after a minor hemorrhage was observed, which the physician determined to be unrelated to the cryoablation devices.The next day, it was reported that the patient was doing fine.It was further reported that during a follow-up, it was discovered that the patient did develop a frostbite wound.A skin graft is planned to treat the injury.
Additional Manufacturer Narrative
D3: manufacturer address 1- tavor building 1, industrial park.H6: impact code was updated.Device evaluation by manufacturer: an iceforce 2.1 cx 90 degree needle was returned for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were noted.The needle was connected to the icefx console, and a two-minute confidence test was performed.The test performed normally.A five-minute freeze in gel was performed and frost was noticed on the shaft.The needle was disassembled and evaluated under a microscope for abnormalities.It was noted that there were abnormalities in the vacuum insulation tubing.The tubing showed some discoloration on the tubing.The frost on the shaft was confirmed.The i-thaw was not confirmed.
Additional Manufacturer Narrative
Device evaluation by manufacturer: an iceforce 2.1 cx 90 degree needle was returned for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were noted.The needle was connected to the icefx console, and a two-minute confidence test was performed.The test performed normally.A five-minute freeze in gel was performed and frost was noticed on the shaft.The needle was disassembled and evaluated under a microscope for abnormalities.It was noted that there were abnormalities in the vacuum insulation tubing.The tubing showed some discoloration on the tubing.The frost on the shaft was confirmed.The i-thaw was not confirmed.
Event or Problem Description
It was reported that frost formed on the needle shaft.An iceforce 2.1 cx 90 degree needle was selected for a renal cryoablation procedure.Three additional needles were used for the procedure, and all tested fine.After each needle was placed in the renal tumor, the freeze began.All four needles started to freeze, and towels were placed under the tubing to prevent frostbite on the skin.An ithaw error appeared on the console for the needles in channel 1a and 4a.There was no temperature displayed, but argon could be heard moving through the console.Nine minutes into the first freeze, a scan was performed, and the ice ball was acceptable to the physician.The needles were moved during the passive thaw to another channel, and the second freeze was started.The needles still reported ithaw errors.It was noted that during the second freeze, the fellow had noticed that two of the needles had started to freeze along the shaft and were freezing the skin in a circular pattern at their entry site.The anesthesiologist used a big hose that blew hot air onto the needles and entry site for approximately 10 minutes before removing the needles.No significant burn was observed after the needles were removed.The patient was kept at the hospital overnight for observation after a minor hemorrhage was observed, which the physician determined to be unrelated to the cryoablation devices.The next day, it was reported that the patient was doing fine.

• Brand Name: ICEFORCE 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; po box 224; 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19645621
• Report Number: 2124215-2024-40175
• Device Sequence Number: 12418269
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: 07290104831003
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/03/2024

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: 01/16/2026
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: 0033231405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male