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 Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a cardiac perforation and pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman laa closure device & delivery system (wds) were selected for use.During the initial transeptal puncture (tsp) using the was and versacross connect system, intracardiac echo (ice) was difficult to visualize the left atrium (la).The versacross connect wire was tented, and while preparing to buzz across the left atrium (la), it was noted the watchman fxd curve sheath and dilator had not advanced over to the la.The physician pulled back the wire to recross, noting again, the sheath and dilator had not advanced over the interatrial septum.At this time, it was noted the wire had perforated the aorta.Physician observed a small circumferential pericardial effusion, noting it was not large enough to drain/treat.Transesophageal echocardiography (tee) and computed tomography (ct) imaging was also completed as part of the assessment.The patient had stable blood pressure, and the implant procedure was discontinued.The patient remained in the hospital for three days.There were no further complications and the patient was discharged.

• 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; ballybrit business park; galway H91 Y 868; EI H91 Y868
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; dc a330; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50548864
• Report Number: 2124215-2026-45816
• Device Sequence Number: 10369101
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 09/30/2026

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: 0038256120
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/02/2026
• 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: Other; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female