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	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion (pe) and cardiac tamponade occurred.The patient was on eliquis at the time of the event.A concomitant procedure consisting of pulsed field ablation and left atrial appendage (laa) closure was performed under transesophageal echocardiography (tee), intracardiac echocardiography (ice), and fluoroscopic guidance.A trace pe was noted at baseline near the ventricular apex.Transseptal puncture was performed using versacross connect along with a watchman access system (was).A 31mm watchman flx pro delivery system and closure device (wds) was inserted and deployed on the first attempt without recapture or repositioning.Following closure device release, was removal, and groin closure, a post-procedure tee sweep demonstrated an increased pe.The patient developed hypotension with cardiac compression.Pericardiocentesis was performed and approximately 180cc of dull-colored fluid was removed.No perforation site was visualized.The patient also required additional blood transfusion.

• 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: 50602043
• Report Number: 2124215-2026-46813
• Device Sequence Number: 13439436
• Product Code: NGV
• UDI-Device Identifier: 00191506004606
• UDI-Public: (01)00191506004606(17)290429(10)39222337
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 0039222337
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 04/30/2026
• 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 Sex: Male