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

Model Number	M004CRBS4000
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the console was unable to recognize the catheter.This is being reported for cancellation of the procedure.During a cryoablation procedure, a smartfreeze cryo console was selected for use to treat atrial fibrillation.The cryoballoon catheter, tubing, and electrical cables were connected to the console; however, after the connections were made, all symbols (coaxial and electrical) on the console appeared red, and the system did not recognize the catheter.A reset and grounding procedure was performed, the cables were reconnected, and all connections were rechecked, but the problem persisted.Subsequently, the catheter was replaced, and the entire procedure was repeated, but the console was still unable to recognize the catheter.Consequently, the procedure was cancelled with the patient being sedated and administered with dormicum.There were no patient complications reported as a result of this event.It is unknown whether the device will be returned for analysis.
Additional Manufacturer Narrative
Block b3 has been updated with additional information received on february 12, 2026.The device is not expected to be returned.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the console was unable to recognize the catheter.This is being reported for cancellation of the procedure.During a cryoablation procedure, a smartfreeze cryo console was selected for use to treat atrial fibrillation.The cryoballoon catheter, tubing, and electrical cables were connected to the console; however, after the connections were made, all symbols (coaxial and electrical) on the console appeared red, and the system did not recognize the catheter.A reset and grounding procedure was performed, the cables were reconnected, and all connections were rechecked, but the problem persisted.Subsequently, the catheter was replaced, and the entire procedure was repeated, but the console was still unable to recognize the catheter.Consequently, the procedure was cancelled with the patient being sedated and administered with dormicum.There were no patient complications reported as a result of this event.It is unknown whether the device will be returned for analysis.

• 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: 23532526
• Report Number: 2124215-2025-82034
• Device Sequence Number: 10026725
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: (01)08714729992691(11)240501(10)SFA01039
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P220032
• 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): 03/04/2026

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: M004CRBS4000
• Device Catalogue Number: M004CRBS4000
• Device Lot Number: SFA01039
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 05/01/2024
• 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: Female