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

Model Number	M635WU50310
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Seal (4070)
Health Effect - Clinical Codes	Stroke/CVA (1770); Fall (1848)
Date of Event	09/06/2026
Type of Reportable Event	Serious Injury

• Brand Name: WATCHMAN FLX?
• 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: 50780271
• Report Number: 2124215-2026-49265
• Device Sequence Number: 16129387
• Product Code: NGV
• UDI-Device Identifier: 08714729860518
• UDI-Public: (01)08714729860518(17)250523(10)29462076
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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 Expiration Date: 05/23/2025
• Device Model Number: M635WU50310
• Device Catalogue Number: M635WU50310
• Device Lot Number: 0029462076
• 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: 09/09/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 05/24/2022
• 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: Hospitalization; Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 226 LB