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

Model Number	M635WU60350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via (b)(6).It was reported that the patient has to remain on medication.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx pro closure device was implanted on (b)(6) 2024.The patient was discharged.During the procedure, one closure device was used with no recapture or repositioning.There was no leak during position, anchor, size and seal (pass) evaluation and the closure device compression ranged from 22 to 26 percent.At an unknown time, it was reported that the patient's closure device was not working.The patient recently had a cardioversion procedure because atrial fibrillation had returned.Before the cardioversion, a magnetic resonance imaging (mri) scan was performed and the physician who performed the mri said that the patient's closure device was not working.When the patient went back to the regular cardiologist, the physician confirmed that the closure device was not working.It was stated that the physician did not give the reason but told the patient that the only option was to have the closure device removed with open heart surgery.The patient did not want to do that so the physician placed the patient back on blood thinner, pradaxa, and told the patient they would have to take it for the rest of his life.
Additional Manufacturer Narrative
B3: aware date was used as event date as the actual event date is not known.

• 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: 50669824
• Report Number: 2124215-2026-47780
• Device Sequence Number: 15990631
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• 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: M635WU60350
• Device Catalogue Number: M635WU60350
• Device Lot Number: 0033089116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 12/19/2023
• 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