MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX? Pro; system, appendage closure, left atrial

Model Number	M635WU60310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion (pe) and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was performed under transesophageal echocardiography (tee) and intracardiac echocardiography (ice) guidance.Baseline imaging demonstrated no pe.Transseptal puncture was performed using a versacross system with a fixed curve sheath.The patient had very challenging laa anatomy with shallow usable depth and both posterior and anterior lobes.Multiple recaptures and repositioning attempts were performed, and a 31mm watchman flx pro closure device was implanted.Approximately two hours after the procedure, while in the post-anesthesia care unit (pacu), the patient became hypotensive.Imaging identified a pe with cardiac tamponade.Pericardiocentesis was performed, and approximately 250 ml of fluid was removed and transfused back to the patient.The patient remained hospitalized beyond the standard of care.

• Brand Name: WATCHMAN FLX? Pro
• 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; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50802473
• Report Number: 2124215-2026-49639
• Device Sequence Number: 13405711
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• UDI-Public: (01)00191506004613(17)290420(10)39144288
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: M635WU60310
• Device Catalogue Number: M635WU60310
• Device Lot Number: 0039144288
• 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: 09/10/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/21/2026
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female