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	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A shaft gas leak was reported.A 1.5 cx 90 degree icephere needle was selected for use in a renal cryoablation procedure.During device integrity testing, prior to insertion into the patient, the needle was submerged in a testing bowl and bubbles occurred along the shaft of the needle at the proximal end near the shaft to handle joint, but not at the joint.The needle was exchanged and the procedure was completed with no reported patient complications.
Event or Problem Description
A shaft gas leak was reported.A 1.5 cx 90 degree icephere needle was selected for use in a renal cryoablation procedure.During device integrity testing, prior to insertion into the patient, the needle was submerged in a testing bowl and bubbles occurred along the shaft of the needle at the proximal end near the shaft to handle joint, but not at the joint.The needle was exchanged and the procedure was completed with no reported patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was returned and 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 and the complaint was not confirmed.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• 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): BOSTON SCIENTIFIC CORPORATION; tavor bldg number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15335922
• Report Number: 2134265-2022-08709
• Device Sequence Number: 6478081
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/12/2022

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: 03/18/2024
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0029132562
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female