MAUDE Adverse Event Report: CARDIOFOCUS CARDIOFOCUS HEARTLIGHT DEVICE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 04/11/2019

Event Type  Injury  

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smart touch sf bidirectional catheter and suffered cerebrovascular accident (cva) requiring tissue plasminogen activator (tpa).Additional information was received on 4/26/2019: the physician's opinion regarding the cause of the adverse event is that it was attributed to the cardiofocus heartlight device placed on the left side of the heart.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CARDIOFOCUS HEARTLIGHT DEVICE
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): CARDIOFOCUS
• MDR Report Key: 17534471
• MDR Text Key: 321100775
• Report Number: MW5141372
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1