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

Model Number	FPRCH6000Z
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the system's touchscreen malfunctioned and the procedure was cancelled due to this event.During a cryoablation procedure, the touchscreen of the visual ice zero cost system malfunctioned.The procedure was cancelled/rescheduled due to this event.
Additional Manufacturer Narrative
Investigation summary: the device was not returned to boston scientific for analysis.A work order for field repair was opened as a result of this event.The field service evaluation confirmed that the screen was unresponsive.The screen was re-interfaced and calibrated, and functionality was returned to normal.
Event or Problem Description
It was reported the system's touchscreen malfunctioned and the procedure was cancelled due to this event.During a cryoablation procedure, the touchscreen of the visual ice zero cost system malfunctioned.Sedation at the time of the malfunction is unknown.The procedure was cancelled/reschedule due to this event.

• Brand Name: VISUAL ICE ZERO COST SYSTEM
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG ROUND LAKE; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22664789
• Report Number: 2124215-2025-51198
• Device Sequence Number: 7767575
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: (01)00867379000006(11)991231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: Other
• Device Model Number: FPRCH6000Z
• Device Catalogue Number: FPRCH6000Z
• Device Lot Number: NV4054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown