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

Lot Number	SFA00770
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error 2 - 00000008 refrigerant flow obstruction detected occurred.During a pulmonary vein isolation (pvi) procedure, a smartfreeze cryoablation system console was selected for use.Approximately half-way through the procedure, after completion of ablations on the left side of the heart, the device was moved to the right side.During ablation, error 2 - 00000008 refrigerant flow obstruction detected occurred.The cryo gas cable connections were checked as well as replacement of the cable, catheter, and tank, however the issue persisted.The procedure was aborted prior to completion of ablations on the right side.There were no patient complications.The device will not be returned, as onsite repair was performed.Replacement of pv1 resolved the issue.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory.The reported allegation is confirmed.The returned pressure valve was tested and it was confirmed that the valve was stuck closed as there was 0 flow and 0 injection pressure during the inflation state.When opening the valve, the plunger head was loose approximately 1 rotation.The 'manufacturing deficiency' code was selected for the reported allegation regarding "refrigerant flow obstruction".
Event or Problem Description
It was reported that error 2 - 00000008 refrigerant flow obstruction detected occurred.During an ablation procedure a smartfreeze cryoablation system console was selected for use.After completion of ablations on the left side of the heart, the device was moved to the right side.During ablation, error 2 - 00000008 refrigerant flow obstruction detected occurred.The cryo cable, catheter, and tank were all replaced, however the issue persisted.The procedure was aborted prior to completion of ablations on the right side.There were no patient complications.The device is expected to be returned for analysis.It was further reported that the procedure was cancelled completely.

• 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 degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18791135
• Report Number: 2124215-2024-08062
• Device Sequence Number: 8343556
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: 08714729992691
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 05/07/2024

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: SFA00770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown