MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost was observed on the needle shaft.This icesphere 1.5 cx 90 degree needle was one of a few needles selected for intercostal nerve cryoablation for pain management.During the procedure, the needle was placed into channel 4b and the test was successful.The physician inserted probe and once placed as desired, began first freeze.Close to the 10 minute mark, the physician noticed the probe was frosting over along the needle close to the skin so a syringe was used to apply warm saline.On the next freeze cycle, the probe was frosting up again, this time more rapidly and closer to the skin.The patient's skin became pink/red and ct imaging showed subcutaneous irritation.The needle was removed and the case was completed successfully with a new needle.It was reported that there were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: icesphere 1.5 cx 90 degree needle (lot 0034129154) was returned any analyzed.Visual inspection revealed no abnormalities.The needle was connected to the icefx console, and a two-minute confidence test was performed without issue.A five-minute freeze in gel was performed and frost was observed on the shaft.The needle was disassembled and evaluated under a microscope revealing dents along the vacuum sleeve.The frost on the shaft was confirmed though analysis.
Event or Problem Description
It was reported that frost was observed on the needle shaft.This icesphere 1.5 cx 90 degree needle was one of a few needles selected for intercostal nerve cryoablation for pain management.During the procedure, the needle was placed into channel 4b and the test was successful.The physician inserted probe and once placed as desired, began first freeze.Close to the 10 minute mark, the physician noticed the probe was frosting over along the needle close to the skin so a syringe was used to apply warm saline.On the next freeze cycle, the probe was frosting up again, this time more rapidly and closer to the skin.The patient's skin became pink/red and ct imaging showed subcutaneous irritation.The needle was removed and the case was completed successfully with a new needle.It was reported that there were no patient complications.Additional information confirmed the returned needle (lot 0034129154) was the correct lot for the reported issue.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20471972
• Report Number: 2124215-2024-64594
• Device Sequence Number: 15321330
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 11/21/2024

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: 06/03/2026
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0034129154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male