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

Model Number	M635WU60200
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	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion and cardiac tamponade occurred.A left atrial appendage closure (laac) procedure was being performed.Prior to the procedure a pericardial effusion was noted on imaging.A watchman fxd curve access system (was) and a 24mm watchman flx pro laa closure and delivery system (wds) were initially selected for use.The was with versacross was posterior for the first transeptal puncture (tsp) and the physician had difficulty getting the sheath across.Another tsp was completed and the wire was put into the appendage and then exchanged for a pigtail catheter.Attempted the 24mm wds, but it was too distally pinched, so it was exchanged for a 20mm wds.The 20mm watchman flx pro was successfully implanted.The pericardial effusion increased in size at the end of the case and the patient blood pressure dropped.A pericardiocentesis was performed and 550cc of bright red blood was drained.The patient was given one bag of blood.The drain was left in place and the patient was sent to the intensive care unit (icu) for observation.The drain has since been removed.The patient was reported as stable and was pending discharge.

• 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: 50602453
• Report Number: 2124215-2026-47205
• Device Sequence Number: 18793049
• Product Code: NGV
• UDI-Device Identifier: 00191506004583
• UDI-Public: (01)00191506004583(17)290601(10)39476952
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 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: M635WU60200
• Device Catalogue Number: M635WU60200
• Device Lot Number: 0039476952
• 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: 09/30/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 06/02/2026
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 136 LB