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	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two leaks were discovered during the test phase.This iceforce 2.1 cx 90 degree needle was selected for a renal cryoablation procedure.During the testing phase, while outside the patient, the needle was fully submerged in saline for integrity testing and two leaks were found near the needle tip and middle of the needle shaft.A new needle was used to complete the procedure successfully without sequela.
Event or Problem Description
It was reported that two leaks were discovered during the test phase.This iceforce 2.1 cx 90 degree needle was selected for a renal cryoablation procedure.During the testing phase, while outside the patient, the needle was fully submerged in saline for integrity testing and two leaks were found near the needle tip and middle of the needle shaft.A new needle was used to complete the procedure successfully without sequela.
Additional Manufacturer Narrative
Device eval by manufacturer: this iceforce 2.1 cx 90 degree needle was returned for analysis.Visual inspection of the exterior of the needle revealed no abnormalities.The needle was connected to the icefx console, and a two-minute confidence test was performed.The test performed normally, without any gas bubble formation.A five-minute freeze in gel was performed to analyze ice ball formation.It was noted that the ice ball formation looked normal and resulted in an ice ball that measured approximately 20mm x 45mm, which is within specification for the iceforce 2.1 cx 90 degree needle.The device passed the two-minute confidence test and produced an ice ball of sufficient size.The reported event of a gas leak was not confirmed.

• Brand Name: ICEFORCE 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor building 1; 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16114097
• Report Number: 2124215-2022-55948
• Device Sequence Number: 6839586
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: 07290104831003
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 05/22/2024
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: 0029470866
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown