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

Model Number	M635WU60350
Medical Device Problem Codes	Migration (4003); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device shift and device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx pro closure device was implanted on (b)(6) 2026.The patient was discharged.During the procedure there were no recaptures performed.The patient had a routine follow up computed tomography (ct) and imaging identified that the closure device shifted proximally.The closure device position was proximal with a leak under the fabric cap, according to the implant team it was under compressed.The patient was cardioverted within 30 days of implant.The patient was asymptomatic and stable at this time.The closure device was successfully removed on (b)(6) 2026 by a cardiothoracic (ct) surgeon via surgical retrieval, the appendage was ligated at the time of the closure device removal and the patient is recovering.

• 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: 50774829
• Report Number: 2124215-2026-49153
• Device Sequence Number: 10422818
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• UDI-Public: (01)00191506004620(17)290301(10)38719787
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 0038719787
• 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: 08/25/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 03/02/2026
• 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: 67 YR
• Patient Sex: Female