MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMARTFREEZE; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Lot Number PXC00170

Device Problem Gas/Air Leak (2946)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

Reportable based on analysis completed following fda approval of the smartfreeze console.A work order was performed onsite by a bsc employee.The system was sealed by replacing the rbs tank to process plate assembly and tightness was checked.It was confirmed that the system is fully functional.

Event Description

The smartfreeze cryo console was selected for use during the ablation procedure to treat atrial fibrillation.It was reported that the connection piece between the gas bottle and the l piece on the hose was leaking during preparation, the thread possibly came loose over time as a result of changing the bottle.Ice formed at the area which leaked.They were able to tighten the connection by hand.The procedure was able to be completed with the original device.No patient complications occurred.The device will not be returned as it needs to be repaired onsite.Reportable based on analysis completed following fda approval of the smartfreeze console.

• 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: 17652768
• MDR Text Key: 322313047
• Report Number: 2124215-2023-46846
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 08714729992691
• UDI-Public: 08714729992691
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PXC00170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1