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

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 01/29/2018

Event Type  Injury  

Event Description

It was reported that phrenic nerve paralysis occurred during a cryo afib procedure.It was noted that the physician used the pentaray catheter and the webster cs catheter to pace the phrenic nerve and check for paralysis.The cryo catheter was not a biosense webster, inc.Product.The patient status at this time was unknown.Additional information received stated that the physician's opinion regarding the cause of the adverse event is that it was related to the arctic front cryoballoon ablation catheter.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17536261
• MDR Text Key: 321153706
• Report Number: MW5143151
• 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: 02/22/2018

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