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

Model Number	M635WU60310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cardiac perforation, pericardial effusion and cardiac tamponade occurred.The patient underwent a concomitant pulse field ablation (pfa) and a left atrial appendage (laa) closure procedure.The physician gained venous access and proceeded with the concomitant procedure.The ablation procedure was successfully completed.A watchman access system (was) and a 31mm watchman flx pro laa closure device & delivery system (wds) were selected to be used.The physician positioned the was in the laa of the patient and then inserted the wds.The closure device was deployed in the patient but was proximal so the closure device was recaptured.The closure device was redeployed and positioned in the laa when it was noted that the device had perforated the laa.Angiogram imaging confirmed the perforation.The closure device was recaptured and redeployed in an ideal position.Transesophageal echocardiogram (tee) imaging showed a large pericardial effusion with cardiac tamponade.The physician performed a pericardiocentesis and drained the effusion, but the effusion did not dissipate.The patient underwent open heart surgery to repair the perforation.There were no other complications that were reported to have occurred as a result of this event.The patient is expected to make a full recovery.

• 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: 50857637
• Report Number: 2124215-2026-50481
• Device Sequence Number: 10053741
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 09/22/2026

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: M635WU60310
• Device Catalogue Number: M635WU60310
• Device Lot Number: 0039552900
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 06/11/2026
• 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: 82 YR
• Patient Sex: Male