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

Lot Number PXC00396

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure a smart freeze cryo console was selected for use.After an effective first ablation in the vein and starting the second ablation the error message 2 - 00000008-1: refrigerant flow obstruction detected appeared on the system.The cryo gas cable was exchanged twice and afterwards the balloon catheter was replaced, but the error message persisted.The procedure was cancelled.No patient complications were reported.It is unknown if the cryo console will be returned for analysis.This report is being sent for the procedure cancellation after patient sedation.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a procedure a smartfreeze cryo console was selected for use.After an effective first ablation in the vein and starting the second ablation the error message 2 - 00000008-1: refrigerant flow obstruction detected appeared on the system.The cryo gas cable was exchanged twice and afterwards the balloon catheter was replaced, but the error message persisted.The procedure was cancelled.No patient complications were reported.It is unknown if the cryo console will be returned for analysis.It was further reported that the procedure was not cancelled but was actually continued and completed successfully with a non-boston scientific system.The device is not expected to be returned for analysis.

Manufacturer Narrative

Additional information was received that indicated the procedure was not cancelled but was actually continued and completed successfully with a non-boston scientific system.The device is not expected to be returned for analysis.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.If this had been known earlier before the submission of the initial mdr the event would have been reassessed to be non-reportable and that report would not have been sent.

• 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; global park, la aurora; 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: 17967193
• MDR Text Key: 326071965
• Report Number: 2124215-2023-57968
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PXC00396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1