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

Model Number	M635WU60310
Medical Device Problem Codes	Migration (4003); Failure to Seal (4070)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via patient call center it was reported the device did not seal.A left atrial appendage (laa) closure procedure was performed, and a 31mm watchman flx pro closure device was implanted on (b)(6) 2026.The patient was discharged.The patient called into the watchman patient call center stating that computed tomography (ct) imaging was completed and the results showed that the left side of the closure device did not seal.A good faith effort was made to the boston scientific (bsc) senior clinical specialist.The bsc senior clinical specialist reported that the patient had routine 90 day computed tomography (ct) imaging on (b)(6) 2026.The imaging physician believed the closure device looked good.A second opinion was obtained and the cardiologist believed there was a leak and possible thrombus present.There was no intervention required at this time.The patient was kept on eliquis medication (5mg bid).

• 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: 50349161
• Report Number: 2124215-2026-44883
• Device Sequence Number: 6063181
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• UDI-Public: (01)00191506004613(17)281202(10)38099336
• 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: Consumer,Health Professional,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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 Model Number: M635WU60310
• Device Catalogue Number: M635WU60310
• Device Lot Number: 0038099336
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026; 09/25/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/10/2026; 09/28/2026
• Date Device Manufactured: 12/03/2025
• 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: 73 YR
• Patient Sex: Male