MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMARTFREEZE CRYOABLATION CONSOLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Patient Problems Nerve Damage (1979); Heart Block (4444)

Event Date 01/05/2024

Event Type  Injury  

Event Description

Septal puncture was performed with rf needle.Description of health hazard - diaphragmatic nerve palsy.Description of health hazard (other) - first-degree atrioventricular block.Progress - it was a combination case of polar fit and carto 3.There was diaphragmatic nerve palsy during rspv cooling.Cf monitoring methods - real time graph; dashboard; vector; visitag.Coloring setting of visitag - tag index.Additional filter for visitag - fot.The physician's opinions on the relationship between the event and the product (comments) - no problem with the product.Were any abnormalities observed prior to use of the product? none.Were any abnormalities observed during use of the product? none.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5150692.

• Brand Name: SMARTFREEZE CRYOABLATION CONSOLE
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18581897
• MDR Text Key: 333957049
• Report Number: MW5150693
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3