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

Model Number	M635WU60270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pericardial Effusion (3271)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage closure (laac) procedure was performed and a 27mm watchman flx pro laa closure device and delivery system (wds) was implanted on (b)(6) 2026.The wds was deployed and protruded approximately one half at the 135-degree angle in the posterior.The device was recaptured.The device was deployed from deep within the anterior on the second deployment.The protrusion in the posterior was approximately one third at the 135-degree angle.The compression rate was 16.7% to 21.5% and there was no leak noted around the device.An accessory left atrial appendage was identified.The physician determined that it could not be sealed with a single watchman implant and decided to release the device.The patient was discharged.At a routine follow up on (b)(6) 2026, a pericardial effusion was identified and a drain was performed.There was no additional information provided.

• 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: 50736220
• Report Number: 2124215-2026-48751
• Device Sequence Number: 10620218
• Product Code: NGV
• UDI-Device Identifier: 00191506004606
• UDI-Public: (01)00191506004606(17)281002(10)37614075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: M635WU60270
• Device Catalogue Number: M635WU60270
• Device Lot Number: 0037614075
• 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: 09/01/2026
• Supplement Date Received by Manufacturer: 09/27/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 10/03/2025
• 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: Required Intervention
• Patient Sex: Unknown