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

Model Number	M635WU60270
Medical Device Problem Codes	Migration (4003); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via patient call center it was reported that device migration occurred and the implant did not seal.A left atrial appendage closure (laac) procedure was performed, and a 27mm watchman flx pro laa closure device was implanted on (b)(6)-2024.The patient called the watchman patient call center and reported the device had become unrooted and rotated, creating a large crevice in the roof of the appendage.The patient was in for transesophageal echocardiography (tee) imaging prior to a pulmonary vein isolation (pvi) procedure when the suspected leak was discovered.The patient reports imaging at the first follow up was normal.Imaging at the one year follow up showed a small leak.Computed tomography (ct) imaging has been scheduled for 14-sep-2026, and a follow up physician visit on (b)(6)-2026.
Event or Problem Description
Reported via patient call center it was reported that device migration occurred and the implant did not seal.A left atrial appendage closure (laac) procedure was performed, and a 27mm watchman flx pro laa closure device was implanted on (b)(6) 2024.The patient called the watchman patient call center and reported the device had become unrooted and rotated, creating a large crevice in the roof of the appendage.The patient was in for transesophageal echocardiography (tee) imaging prior to a pulmonary vein isolation (pvi) procedure when the suspected leak was discovered.The patient reports imaging at the first follow up was normal.Imaging at the one year follow up showed a small leak.Computed tomography (ct) imaging has been scheduled for (b)(6)2026, and a follow up physician visit on 18-sep-2026.It was further reported, after speaking with the implanting physician, that there was no leak found at the one year follow up appointment.The device however did not still meet all of the position, anchor, size and seal (pass) criteria at that time.
Additional Manufacturer Narrative
B5: describe event or problem - updated h6 device code: failure to seal a050705 - removed per additional information.

• 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: 50736615
• Report Number: 2124215-2026-48769
• Device Sequence Number: 10620714
• Product Code: NGV
• UDI-Device Identifier: 00191506004606
• UDI-Public: (01)00191506004606(17)270513(10)34023310
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: M635WU60270
• Device Catalogue Number: M635WU60270
• Device Lot Number: 0034023310
• 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: 09/02/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 05/13/2024
• 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: 70 YR
• Patient Sex: Unknown