MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RF NEEDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Needle Stick/Puncture (2462); Pericardial Effusion (3271)

Event Date 08/19/2023

Event Type  Injury  

Event Description

During the af procedure by (b)(6), when brocken brough was performed by inserting an rf needle (boston scientific) using a swartz introducer, it stuck to the posterior wall and caused cardiac tamponade.An echocardiogram confirmed the accumulation of pericardial effusion, and the blood pressure decreased.After that, drainage was performed and the pericardial fluid was removed, and the blood pressure recovered.The occurrence of this event discontinued the procedure.The hospital discarded the reported introducer.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RF NEEDLE
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17605352
• MDR Text Key: 321813282
• Report Number: MW5144881
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1