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	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak from the needle shaft occurred.An icesphere 1.5 cx 90 degree needle was selected for treatment in the lung.During testing, gas/air was leaking from the needle shaft.Troubleshooting was performed by trying another channel.Another icesphere was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.Device evaluated by mfr: the complaint device was returned for product analysis.The complaint device was tested for an air leak with none found.No air bubbles were seen coming from the needle shaft or the handle joints.The device was ran through a freeze cycle and produced an iceball of adequate size.There was no issues found with the functionality of the device.
Event or Problem Description
It was reported that a leak from the needle shaft occurred.An icesphere 1.5 cx 90 degree needle was selected for treatment in the lung.During testing, gas/air was leaking from the needle shaft.Trouble shooting was performed by trying another channel.Another icesphere was used to completed the procedure.There were no patient complications.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavorbuilding1,industrial park; 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: 15571699
• Report Number: 2124215-2022-39791
• Device Sequence Number: 2985013
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 11/09/2022

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: 05/05/2024
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0029470813
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown