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

Model Number	M004CRBS4000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).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
It was reported that "error 1-00000020-2 outer balloon pressure (obp) too high" occurred.Subsequently, the procedure was cancelled.A smartfreeze cryoablation console was selected for use.The error message "the outer balloon pressure too high" appeared.Troubleshooting was performed but was unable to resolve the issue.Subsequently, the procedure was cancelled.There were no patient complications reported as a result of this event.No further details were provided to explain when the issue occurred or if the patient was sedated prior to this cancellation.Field service was provided to the device, but no technical issues were identified.Good faith efforts (gfe) has been sent to identify if the device will be returned for analysis.This is being reported for procedure cancellation with sedation status unknown.
Additional Manufacturer Narrative
Investigation summary: based on the available information, the root cause of the error 1-00000020-2 outer balloon pressure (obp) too high presenting which resulted in an aborted/cancelled procedure could not be established, as the product has not been returned for analysis.Device history record review: service history was reviewed for the reported device and there were no service records after the console was installed at the facility.As there were no cases or complaints created prior to the currently reported events to suggest performance issues, it was considered fully functional with no issues from that date until the reported event date.Device technical analysis: field service was provided.Review of those records showed that no issues were identified with the device.The device passed all relevant testing.Additionally, boston scientific has made three attempts to retrieve the device, however no response was received; the device is not expected to be returned; therefore, a failure analysis of the complaint device could not be completed.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Investigation conclusion: based on the available information, boston scientific's investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the ifu was not followed.
Event or Problem Description
It was reported that "error 1-00000020-2 outer balloon pressure (obp) too high" occurred.Subsequently, the procedure was cancelled.A smartfreeze cryoablation console was selected for use.The error message "the outer balloon pressure too high" appeared.Troubleshooting was performed but was unable to resolve the issue.Subsequently, the procedure was cancelled.There were no patient complications reported as a result of this event.No further details were provided to explain when the issue occurred or if the patient was sedated prior to this cancellation.Field service was provided to the device, but no technical issues were identified.Good faith efforts (gfe) has been sent to identify if the device will be returned for analysis.This is being reported for procedure cancellation with sedation status unknown.

• 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: 23865614
• Report Number: 2124215-2025-92342
• Device Sequence Number: 20165785
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: (01)08714729992691(11)201119(10)PXC00131
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: PXC00131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 11/19/2020
• 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: Unknown