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

Model Number	FPRPR3602
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3 manufacturer address 1: tavor building 1, industrial park.
Event or Problem Description
It was reported that there was a gas leak from the needle shaft.An iceforce 2.1 cx 90 degree needle was selected for a cryoablation procedure to treat renal cell cancer.During the integrity test, however, the needle was completely submerged in saline, and a continuous streak of bubbles was seen coming out of the needle shaft.No damage was seen by the operating team.Another iceforce needle was used to complete the procedure, and there were no patient complications reported.
Event or Problem Description
It was reported that there was a gas leak from the needle shaft.An iceforce 2.1 cx 90 degree needle was selected for a cryoablation procedure to treat renal cell cancer.During the integrity test, however, the needle was completely submerged in saline, and a continuous streak of bubbles was seen coming out of the needle shaft.No damage was seen by the operating team.Another iceforce needle was used to complete the procedure, and there were no patient complications reported.
Additional Manufacturer Narrative
D3 manufacturer address 1: tavor building 1, industrial park device evaluated by manufacturer: an iceforce 2.1 cx 90 degree needle (lot# 29332672) was returned to arden hills cis for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were noticed.The needle was connected to the icefx console, the two-minute pretest was performed, and during this test, gas bubbles were noticed escaping from the handle to shaft junction on the device.The needle was disassembled, and it was noticed that there was abnormal glue surrounding the needle shaft, and what appeared to be cracking in the glue.The reported event of a leak in the handle of the device was confirmed and likely caused by glue abnormalities in the handle to shaft junction.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16811729
• Report Number: 2124215-2023-18601
• Device Sequence Number: 5992258
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: 07290104831003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 05/03/2024
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: 0029332672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown