MAUDE Adverse Event Report: CARDIOFOCUS, INC. HEATLIGHT LASER BALLOON; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported by the caller that during an afib procedure the patients phrenic nerve was damaged by the cardio focus laser balloon.A soundstar catheter was the only bwi product being used for the procedure was was not involved in the injury.The soundstar catheter was disposed of.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HEATLIGHT LASER BALLOON
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): CARDIOFOCUS, INC.
• MDR Report Key: 17488508
• MDR Text Key: 320686449
• Report Number: MW5121207
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1