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

Lot Number SFA00770

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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: 18791135
• MDR Text Key: 336989364
• Report Number: 2124215-2024-08062
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: SFA00770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1