MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. SMARTTOUCH SF CATHETAR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 03/13/2023

Event Type  Injury  

Event Description

It was reported during an atrial fibrillation case, a pericardial effusion was noticed.The caller reported there was a drop in blood pressure in the patient that the anesthesiologist was treating.The pericardial effusion was confirmed by ultrasound ice.The caller reported that the medical intervention provided was a pericardiocentesis and 425cc of fluid was removed.The patient was reported to be in stable condition.The physician stated they are not concerned regarding the stsf catheter.The possibility of it happening exists when going transseptal or while placing the cs catheter.The following bwi devices were in use: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SMARTTOUCH SF CATHETAR
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.
• MDR Report Key: 17488435
• MDR Text Key: 320698951
• Report Number: MW5121134
• 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: Other
• Type of Report: Initial
• Report Date: 04/11/2023

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