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

Model Number	FPRPR3601
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3: manufacturer address 1- (b)(6).
Event or Problem Description
It was reported a gas/air leak occurred on the shaft of the device.During preparation, an icepearl 2.1 cx 90 degree needle was reported to have a gas/air leak from the shaft of the device, an air bubble was present.To troubleshoot the event the device was switched to another channel, device was not used in the procedure.Another device of a different model was used to complete the procedure.No patient complications reported.
Additional Manufacturer Narrative
D3: manufacturer address 1- tavor building 1, industrial park.Device evaluation by manufacturer: an icepearl 2.1 cx 90 degree needle (lot# 30757927) was returned to arden hills cis for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were initially noticed.The needle was connected to the icefx console, and a two-minute confidence test was performed.It was discovered during this confidence test that gas bubbles were forming at the distal end of the handle that connects to the needle shaft.The needle was disassembled and evaluated under a microscope.It was discovered that there appeared to be small hairline cracks in the glue connecting the handle to the shaft.The reported event of a gas leak from the needle shaft was not confirmed; however, it was confirmed that the device leaked gas from the handle to shaft junction.
Event or Problem Description
It was reported a gas/air leak occurred on the shaft of the device.During preparation, an icepearl 2.1 cx 90 degree needle was reported to have a gas/air leak from the shaft of the device, an air bubble was present.To troubleshoot the event the device was switched to another channel, device was not used in the procedure.Another device of a different model was used to complete the procedure.No patient complications reported.

• Brand Name: ICEPEARL 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19005774
• Report Number: 2124215-2024-19129
• Device Sequence Number: 18501349
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 12/14/2024
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: 0030757927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown