MAUDE Adverse Event Report: BTG ROUND LAKE VISUAL-ICE CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH6000
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was canceled due to no ice formation during preparation.An icefx cryoablation system was used together with a 5 icerod i-thaw prostate kit for a cryoablation procedure to treat prostate cancer.During testing, however, the i-thaw needles did not produce ice.A new needle was exchanged on the console, but the issue was not resolved.Due to this, the procedure was rescheduled to another date.The patient condition was stable.
Additional Manufacturer Narrative
D1: brand name corrected.D4: model number and catalog number corrected.D4: lot number, serial number, expiration date and udi # updated.G4: g4: pma/510(k) # corrected.H4: device manufacture date updated.
Event or Problem Description
It was reported that a procedure was canceled due to no ice formation during preparation.An icefx cryoablation system was used together with a 5 icerod i-thaw prostate kit for a cryoablation procedure to treat prostate cancer.During testing, however, the i-thaw needles did not produce ice.A new needle was exchanged on the console, but the issue was not resolved.Due to this, the procedure was rescheduled to another date.The patient's condition was stable.

• Brand Name: VISUAL-ICE CRYOABLATION SYSTEM
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG ROUND LAKE; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): GALIL MEDICAL; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16009714
• Report Number: 2124215-2022-52419
• Device Sequence Number: 5784019
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 00867379000006
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K113860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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: 05/18/2015
• Device Model Number: FPRCH6000
• Device Catalogue Number: FPRCH6000
• Device Lot Number: VL0204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1988
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male