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

Model Number	FPRCH6000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Limb Fracture (4518); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 : the date of event was unknown and approximated based on the date that we became aware of the adverse event.
Event or Problem Description
It was reported the patient experienced a fracture of the femur at the location of the tumor.This visual-ice cryoablation system was used to treat a tumor in the femur of a young patient.Post-procedure the patient had experienced a fracture of the femur at the location of the tumor.The patient was admitted for further care; however, no further details were approved to be disclosed by the facility director.
Additional Manufacturer Narrative
B3 : the date of event was unknown and approximated based on the date that we became aware of the adverse event.
Event or Problem Description
It was reported the patient experienced a fracture of the femur at the location of the tumor.This visual-ice cryoablation system was used to treat a tumor in the femur of a young patient.Post-procedure the patient had experienced a fracture of the femur at the location of the tumor.The patient was admitted for further care; however, no further details were approved to be disclosed by the facility director.Additional information was received from the physician who indicated there was some miscommunication initially regarding this case, and it was concluded that the fracture was not related to the cryoablation procedure.Further information regarding the case was not able to be disclosed.

• 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 INC.; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17869358
• Report Number: 2124215-2023-54336
• Device Sequence Number: 5493465
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: 00867379000006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FPRCH6000
• Device Catalogue Number: FPRCH6000
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown