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

Model Number	FPRPR3573
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Insufficient Heating (1287)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: estimated as the event date was not provided.D3 manufacturer address: (b)(6).
Event or Problem Description
It was reported that frost formed on the device and the patient experienced a skin burn.The patient was being treated for a breast tumor.The icefx cryoablation system and an icesphere 1.5 cx 90 degree needle were for selected use.Initially, the i-thaw mode was not working on any port.After troubleshooting, the issue was resolved, but then after 5 minutes of freezing, the issue occurred again.The fault codes 80-30 and 40-08 were received.The user pressed the pause button; however, the needle kept freezing and the iceball continued to grow.They waited a few minutes with no changes to the system.Frost was observed on the device and a burn was observed on the skin of the patient.The argon gas was shut off.The needle was removed from the patient.The procedure was completed.The burn was treated with silver sulfadiazine cream.The patient was reported to be ok and there were no further complications.
Additional Manufacturer Narrative
B3: date of event: estimated as the event date was not provided.D3: manufacturer address: tavor building 1, industrial park.D4: lot number updated under brand name section.
Event or Problem Description
It was reported that frost formed on the device and the patient experienced a skin burn.The patient was being treated for a breast tumor.The icefx cryoablation system and an icesphere 1.5 cx 90 degree needle were for selected use.Initially, the i-thaw mode was not working on any port.After troubleshooting, the issue was resolved, but then after 5 minutes of freezing, the issue occurred again.The fault codes 80-30 and 40-08 were received.The user pressed the pause button; however, the needle kept freezing and the iceball continued to grow.They waited a few minutes with no changes to the system.Frost was observed on the device and a burn was observed on the patient's skin.The argon gas was shut off.The needle was removed from the patient.The procedure was completed.The patient's skin was treated with silver sulfadiazine cream.The patient was reported to be ok and there were no further complications.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor building; 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: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21174372
• Report Number: 2124215-2025-01300
• Device Sequence Number: 15819704
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: (01)07290104831133(17)250112(10)30942733
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: Other
• Device Expiration Date: 01/12/2025
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0030942733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/15/2025
• Date Device Manufactured: 01/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ICEFXTM CRYOABLATION SYSTEM; ICEFXTM CRYOABLATION SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown