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

Model Number	M635WU60240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.A 24mm watchman flx pro laa closure device & delivery system (wds) were selected for use.Transesophageal echocardiography (tee) imaging noted a trace effusion prior to the procedure.The initial transeptal puncture (tsp) was difficult to perform due to a sharp posterior-inferior bend in the patient anatomy.The physician attempted to cross the septum several times using the versacross connect wire, adding two different sheath/dilator bends for greater reach.After physician deployed the closure device, and completed a sweep, tee imaging showed no change in effusion.Approximately thirty minutes post deployment, the patient's blood pressure dropped.Tee imaging noted the effusion near the apex of the left ventricle.Physician performed a pericardiocentesis to treat the effusion, draining an unknown amount of dull colored fluid.Patient was stabilized and was admitted to intensive care unit.There were no further complications and approximately three days post procedure, the patient was discharged.

• 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; dc a330; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50548865
• Report Number: 2124215-2026-46016
• Device Sequence Number: 10369102
• Product Code: NGV
• UDI-Device Identifier: 00191506004590
• UDI-Public: (01)00191506004590(17)290412(10)39074825
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,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: M635WU60240
• Device Catalogue Number: M635WU60240
• Device Lot Number: 0039074825
• 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: 08/07/2026
• Supplement Date Received by Manufacturer: 09/18/2026; 08/18/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/23/2026; 09/29/2026
• Date Device Manufactured: 04/13/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male