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

Lot Number	SFA00969
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The smartfreeze cryo console was selected for use in cryo pulmonary vein isolation.During the preparation, the catheter was connected to the cryo console, and the polarmap was properly advanced out of the inner lumen.The console maintained a proper vacuum.However, during inflation under saline, an error occurred, and the balloon automatically deflated.The error indicated that the outer balloon pressure was too high (error 1-00000020-2).After clearing the error and attempting inflation again, the same issue arose, leading to automatic deflation within less than 10 seconds.Subsequently, the balloon was replaced.The second polarx fit balloon underwent the same preparation and was connected using the original cable and gas tubing.Despite a functioning vacuum, the balloon deflated automatically upon inflation due to the same error.Replacing the cryo gas cable did not resolve the issue.A third polarx fit balloon was then used with the second cryo cable, but the problem persisted.Field support was contacted, the electrical cable was replaced, yet the error remained.Even after switching the gas tank and rebooting the smartfreeze console, the error continued.Ultimately, the procedure was cancelled due to failure of the cryoablation system.The procedure was cancelled while the patient was sedated under anesthesia.The device is anticipated to remain in the field and not be returned due to servicing requirements.During a field service inspection, the covers were removed to inspect all internal connections.No issues were found none were loose, broken, or misplaced.Test equipment was set up, and several ablations were run for 3 minutes each without any problems.Two sets of catheters and cryo cables were used, both functioning correctly.Following a discussion and image exchange to verify component specifications, field service engineer decided to complete the function check and test the unit with the service tool.The service tool operated flawlessly, passing all tests.No parts were replaced on this console, except for a tubing removed for testing, which was subsequently replaced as part of standard service tool usage.Temperature may influence low-pressure conditions and advise the possibility of storing the console in a warmer hallway to maintain the gas tank's temperature.The lab's electrical outlets behaved unusually, with the ground indicator on both a tester and a protected power strip flickering constantly, whereas normally, these lights are solid and steady.This was an abnormal behavior for the test devices.All outlets in the lab exhibited the same behavior.Further review of the error log files revealed that a field service engineer needs to visit the site to replace the cryoconnector, sv9, and sv9 extension tubing.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20139075
• Report Number: 2124215-2024-55344
• Device Sequence Number: 3187512
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: 08714729992691
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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 Lot Number: SFA00969
• 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: 08/13/2024
• Initial Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown