MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the needle gas leak occurred.During preparation for a renal cell carcinoma (rcc) treatment procedure, integrity testing of an icesphere 1.5 cx 90 degree cryoablation needle revealed a gas leak at an unknown location.The needle was exchanged and the procedure was completed with no patient complications.
Additional Manufacturer Narrative
D3 - manufacturer address 1: tavor building 1, industrial park.
Event or Problem Description
It was reported the needle gas leak occurred.During preparation for a renal cell carcinoma (rcc) treatment procedure, integrity testing of an icesphere 1.5 cx 90 degree cryoablation needle revealed a gas leak at an unknown location.The needle was exchanged and the procedure was completed with no patient complications.It was further reported that the leak was coming from the grey tube to handle joint.
Event or Problem Description
It was reported the needle gas leak occurred.During preparation for a renal cell carcinoma (rcc) treatment procedure, integrity testing of an icesphere 1.5 cx 90 degree cryoablation needle revealed a gas leak at an unknown location.The needle was exchanged and the procedure was completed with no patient complications.It was further reported that the leak was coming from the grey tube to handle joint.
Additional Manufacturer Narrative
D3 - manufacturer address 1: (b)(4).Device eval by manufacturer: visual analysis of the needle showed no obvious damage.The needle was leak and performance tested.An air leak was seen from the handle-shaft connection.The shrink wrap was removed from the handle, and microscopic analysis of this connection showed a lack of glue.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• 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 building number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15289012
• Report Number: 2134265-2022-08655
• Device Sequence Number: 7138990
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 11/13/2022

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: 03/23/2024
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0029221056
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 08/31/2022; 10/21/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/27/2022; 11/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown