MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FXD Curve? Access System; system, appendage closure, left atrial

Model Number	M635TU80020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that asystole occurred.A left atrial appendage (laa) closure procedure was being performed under intracardiac echocardiography (ice) and transesophageal echocardiography (tee) guidance using a watchman fxd double curve access system (was) and versacross connect.While the physician was coming down from the superior vena cava in preparation for transseptal puncture with both devices, the patient developed asystole lasting approximately 20 to 30 seconds.External pacing was initiated, and the patient subsequently returned to atrial fibrillation.Imaging confirmed no pericardial effusion, and the physician elected to proceed with the procedure.Prior to watchman closure device implantation, cardioversion was attempted but was unsuccessful in restoring sinus rhythm.The procedure was completed as planned.The patient remained stable with no further reported complications.The patient was discharged the same day.

• Brand Name: WATCHMAN FXD Curve? Access System
• Common Device Name: system, appendage closure, left atrial
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50805549
• Report Number: 2124215-2026-49501
• Device Sequence Number: 18303779
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M635TU80020
• Device Catalogue Number: M635TU80020
• Device Lot Number: 0039217015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male