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

Model Number	FPRPR3602
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device's vacuum sleeve failed and the patient experienced a skin burn.During the procedure to treat a renal cell carcinoma (rcc), an iceforce 2.1 cx 90 degree needle was chosen for treatment.General anesthesia was administered at the start of the procedure.It was reported the device's vacuum sleeve failed and that ice was observed on the needle shaft.Patient's skin was burned, the degree of burn is unknown.The procedure was cancelled/reschedule due to this event.
Additional Manufacturer Narrative
Manufacturer address 1: tavor building 1, industrial park.Device evaluation by manufacturer: functional testing was unable to be performed conventionally because the needle cable was cut.The needle was disassembled, and the vacuum sleeve was stuck within the shaft and unable to be removed.The vacuum sleeve tester was inserted into the needle shaft and frost was observed forming on the needle shaft, indicating a failure of the vacuum sleeve component.The vacuum sleeve tester rod was unable to be completely inserted through the vacuum sleeve, indicating some sort of blockage within the vacuum sleeve.The needle was viewed under x-ray, since the vacuum sleeve was unable to be removed from the needle shaft, and it was observed that the vacuum sleeve was collapsed and flattened within the undamaged needle shaft.The reported event was confirmed.
Event or Problem Description
It was reported the device's vacuum sleeve failed and the patient experienced a skin burn.During the procedure to treat a renal cell carcinoma (rcc), an iceforce 2.1 cx 90 degree needle was chosen for treatment.General anesthesia was administered at the start of the procedure.It was reported the device's vacuum sleeve failed and that ice was observed on the needle shaft.Patient's skin was burned, the degree of burn is unknown.The procedure was cancelled/reschedule due to this event.

• 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 bldg number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19556918
• Report Number: 2124215-2024-36552
• Device Sequence Number: 6806424
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: 07290104831003
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 07/25/2024

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 Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown