MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX?; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635WU50310
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device did not seal.A left atrial appendage closure (laac) procedure was performed.A watchman fxd double curve access system (was) and a 31mm watchman flx pro laa closure device & delivery system (wds) was selected for use.The 31mm closure device was successfully implanted in the patient on (b)(6) 2023.The patient was discharged.On (b)(6) 2025, during routine follow up transesophageal echocardiography (tee) imaging, it was noted that the patient had a peri-device leak.The physician planned to coil the leak.The patient did not have any symptoms or medical concerns prior to finding the leak.On (b)(6) 2025, a pre-coiling tee demonstrated a 3mm leak.The physician proceeded with coiling considering the leak was a new finding, therefore on (b)(6) 2025, the physician placed coils to close the leak.There were no patient complications, and the patient was discharged the same day.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24021207
• Report Number: 2124215-2026-01557
• Device Sequence Number: 16090789
• Product Code: NGV
• UDI-Device Identifier: 08714729860518
• UDI-Public: (01)08714729860518(17)251201(10)30641691
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: 12/01/2025
• Device Model Number: M635WU50310
• Device Catalogue Number: M635WU50310
• Device Lot Number: 0030641691
• 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: 12/29/2025
• Initial Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 12/02/2022
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male