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

Model Number	M635WU50270
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device did not seal.A left atrial appendage (laa) closure procedure was performed, and a 27mm watchman flx closure device was implanted on (b)(6) 2021.The patient was subsequently discharged.On (b)(6) 2026, the patient presented for a transesophageal echocardiogram (tee) as part of a planned valve repair procedure.During the examination, the tee physician informed the implanting physician of the presence of the closure device and identified a visible leak around the device fabric cap.The closure device appeared to be in a position relatively unchanged from the time of the original implant.Imaging demonstrated a large shoulder (between 1/3 to 2/3) on the device in high-angle views.In addition, a 2mm leak was observed beneath the fabric cap visualized most on the 90-degree tee view.The implanting physician is recommending surgical removal of watchman closure device due to a combination of the leak, device position, and lack of device endothelialization if patient is a candidate for surgical valve repair.

• 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: 50600711
• Report Number: 2124215-2026-47138
• Device Sequence Number: 10570768
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)240408(10)27114148
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2024
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0027114148
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 04/09/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Male