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	Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Date of Event	09/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that st segment elevation occurred.A left atrial appendage (laa) closure procedure was being performed under transesophageal echocardiography (tee) guidance and general anesthesia.A watchman fxd double curve access system (was) was used with versacross connect for transseptal puncture then a watchman trusteer access system was inserted.A 24mm watchman flx pro delivery system and closure device (wds) was initially deployed.Following deployment, st segment elevation was noted on the ekg along with hypotension, and it did not immediately resolve.The physician performed a right coronary angiogram.No coronary spasm was identified, and no air was visualized within the patient.Following angiography, the st segments returned to baseline and the patient remained hemodynamically stable.In the physicians opinion, the event was related to air introduction into the wds.A 20mm wds was subsequently prepared, inserted, deployed, and released without further issue.The patient remained stable with no additional reported complications, and was discharged home.

• 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: 50842879
• Report Number: 2124215-2026-50221
• Device Sequence Number: 10039792
• Product Code: NGV
• UDI-Device Identifier: 00191506004590
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• 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: M635WU60240
• Device Catalogue Number: M635WU60240
• Device Lot Number: 0038843461
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 03/16/2026
• 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 Age: 83 YR
• Patient Sex: Female