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	11/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle shaft was leaking gas.During device preparation for the cryoablation procedure, there was a gas bubble observed on the shaft of the icepearl 2.1 cx 90 degree needle.The device did not make contact with the patient.The needle was replaced, and the procedure was completed.There were no reported adverse consequences to the patient.
Event or Problem Description
It was reported that the needle shaft was leaking gas.During device preparation for the cryoablation procedure, there was a gas bubble observed on the shaft of the icepearl 2.1 cx 90 degree needle.The device did not make contact with the patient.The needle was replaced, and the procedure was completed.There were no reported adverse consequences to the patient.
Additional Manufacturer Narrative
Device media analysis: the device was returned for analysis.The device was hooked up to the in-house console and functional testing was performed.During initial testing, air was seen coming from the proximal end of the needle handle.Disassembly of the device confirmed a gas leak from the needle handle.Component failure of the o-ring in the handle was the cause of the handle leak.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL ISRAEL; tavor bldg 1; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15880591
• Report Number: 2124215-2022-47279
• Device Sequence Number: 5398530
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/12/2023

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: 08/24/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U3539
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown