MAUDE Adverse Event Report: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT

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

Event Type  Injury  

Event Description

'during procedure to treat atrial fibrillation (a fib).A farastar ablation generator was selected for use.It was reported that error 303/error 201 occurred.Console showed multiple 303 errors, catheter placement was correct and repositioned, finally it resulted in a 201 error.Replaced cable and restarted console.Console had been used the prior day without any problems.Procedure was completed via alternate method(carto system).No patient complications reported, console is expected to be returned for analysis.-(b)(4).!this report reflects information received by fda in the form of a notification per 803.22 (b) (2).

• Brand Name: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT
• Type of Device: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT
• MDR Report Key: 17435019
• MDR Text Key: 320253460
• Report Number: MW5120398
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention