MAUDE Adverse Event Report: BTG ROUND LAKE ICEFX SYSTEM US REFURBISHED; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH8000-02R
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported insufficient ice occurred.A icefx cryoablation us system was chosen to complete a cryoablation procedure, insufficient ice occurred during the procedure.The details of how the procedure was competed were not provided.There were no patient complications as a result of this event.

• Brand Name: ICEFX SYSTEM US REFURBISHED
• 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: 22096424
• Report Number: 2124215-2025-34247
• Device Sequence Number: 20566841
• Product Code: GEH
• UDI-Device Identifier: 00859019006677
• UDI-Public: (01)00859019006677(11)180820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: Health Professional
• Device Model Number: FPRCH8000-02R
• Device Catalogue Number: FPRCH8000-02R
• Device Lot Number: IF0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/28/2025
• Date Device Manufactured: 08/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown