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

Lot Number	PXC00425
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
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
This event is being reported for aborted/cancelled procedure with a patient under sedation.During a cryo ablation with polarx fit a smartfreeze cryo console was selected for use.Following a gas bottle exchange, no temperatures recorded reached lower than -30 degrees.Flow and pressure during ablation where about 9000 and 590.Troubleshooting includes restarting the console, disconnect and reconnect the gas bottle, and exchange of the gas cable.The issue could not be resolved.The patient was under general anesthesia when the procedure was cancelled/ rescheduled.The device is not expected to return the physician request onsite service.
Additional Manufacturer Narrative
Device technical analysis: upon receipt at boston scientific's post market laboratory the returned flowmeter was tested by connecting to gold system and performing the flowmeter verification test.It was found that the flowmeter was out of calibration, reading higher than it should.This can contribute to warmer balloon temperatures.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.During a cryo ablation with polarx fit a smartfreeze cryo console was selected for use.Following a gas bottle exchange, no temperatures recorded reached lower than -30 degrees.Flow and pressure during ablation where about 9000 and 590.Troubleshooting includes restarting the console, disconnect and reconnect the gas bottle, and exchange of the gas cable.The issue could not be resolved.The patient was under general anesthesia when the procedure was cancelled/ rescheduled.The device is not expected to return the physician request onsite service.

• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18735986
• Report Number: 2124215-2024-08516
• Device Sequence Number: 20428111
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: 08714729992691
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/16/2024

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 Lot Number: PXC00425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown