MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMARTFREEZE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	M004CRBS400Z0
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
During a medical event, a smartfreeze device was chosen for operation.An error was reported, specifically an rfo, indicating a refrigerant flow obstruction detected.This incident took place external to the patient.There is no information available regarding the device's return.Consequently, the procedure was terminated.It remains unclear whether the patient was under sedation when the issue arose.It is unknown if the device will be available for return.
Additional Manufacturer Narrative
Correction to the initial mdr in block h6.B5: describe event or problem - updated.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
During a medical event, a smartfreeze device was chosen for operation.An error was reported, specifically an rfo, indicating a refrigerant flow obstruction detected.This incident took place external to the patient.There is no information available regarding the device's return.Consequently, the procedure was terminated.It remains unclear whether the patient was under sedation when the issue arose.It is unknown if the device will be available for return.During a field service visit, the cryo-connector, micron filter, and check valve sub-assembly (cv6) were replaced; however, the rfo error persisted.Further inspection revealed a leak in the crbs solenoid valve assembly sv1.In the second service intervention, both sv1 and the crbs solenoid valve assembly sv9 were replaced.However, the ablation test failed due to an outer balloon pressure error.A third replacement was conducted, which included the crbs cryo-connector with tygon tubing assembly and the crbs sv9 extension tubing assembly.This final intervention successfully resolved both the functional and ablation test issues.

• Brand Name: SMARTFREEZE
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20292424
• Report Number: 2124215-2024-59691
• Device Sequence Number: 18164207
• Product Code: OAE
• UDI-Device Identifier: 08714729997481
• UDI-Public: (01)08714729997481(11)210830(10)PXC00315
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: M004CRBS400Z0
• Device Catalogue Number: M004CRBS400Z0
• Device Lot Number: PXC00315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown