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

Patient Problem Nerve Damage (1979)

Event Type  malfunction  

Event Description

It was reported that the patient experienced a phenic nerve injury (pni).During a cryo balloon catheter ablation (cbca) procedure to treat atrial fibrillation a polarx catheter was selected for use.When the right inferior pulmonary vein (ripv) was being ablated the patient's diaphragm movement slowed down.Ablation was immediately ceased and the balloon was denate, a non-boston scientific catheter was inside the heart while the issue occurred.The procedure was completed with no patient complications.The device is not expected to be returned for analysis due to disposal.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BEEAT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• MDR Report Key: 18040763
• MDR Text Key: 327135847
• Report Number: MW5147526
• Device Sequence Number: 1
• Product Code: OAE
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: POLARX CATHETER