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	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion and cardiac perforation occurred.A left atrial appendage closure (laac) procedure was being performed.A watchman access system (was) and a 27mm watchman flx pro laa closure device & delivery system (wds) were selected for use.While the physician attempted to recapture the closure device, an effusion was noted.While examining transesophageal echocardiography (tee) images, it was observed the sheath tip was now in the transverse sinus, noting fluid was accumulating.It was noted there was a perforation of the posterior wall.The physician elected to discontinue the implant procedure as a result of procedure complications.Fluids were given to the patient, but no further intervention was required to manage the pericardial effusion.

• 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: 50789769
• Report Number: 2124215-2026-49400
• Device Sequence Number: 18522918
• Product Code: NGV
• UDI-Device Identifier: 00191506004606
• UDI-Public: (01)00191506004606(17)290628(10)39690116
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 0039690116
• 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: 09/09/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 06/29/2026
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 151 LB