MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX? PRO; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635WU60400
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); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cardiac perforation, pericardial effusion and cardiac tamponade occurred.A left atrial appendage closure (laac) procedure was being performed concomitantly following ablation procedures.A watchman fxd curve access system (was) and a 40mm watchman flx pro laa closure device & delivery system (wds) were selected for use.After one deployment with the device there was one recapture.A second deployment in the appendage was completed.Contrast was used and no leaks were noted and the position, anchor, size and seal (pass) criteria was met.During the final measurements, the physician was notified of low blood pressure.The physician did a sweep with the intracardiac echo (ice), and a pericardial effusion was found on the right side.The physician decided to release the device and started a pericardiocentesis.Blood was still collecting in the pericardial space.Cardiovascular surgery was consulted.Emergent surgery was needed to stop the bleeding.It was noted the patient was on plavix at the time of the procedure.There were no further complications.
Additional Manufacturer Narrative
The device was not returned for analysis as the device remains implanted; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that cardiac perforation, pericardial effusion and cardiac tamponade occurred.A left atrial appendage closure (laac) procedure was being performed concomitantly following ablation procedures.A watchman fxd curve access system (was) and a 40mm watchman flx pro laa closure device & delivery system (wds) were selected for use.After one deployment with the device there was one recapture.A second deployment in the appendage was completed.Contrast was used and no leaks were noted and the position, anchor, size and seal (pass) criteria was met.During the final measurements, the physician was notified of low blood pressure.The physician did a sweep with the intracardiac echo (ice), and a pericardial effusion was found on the right side.The physician decided to release the device and started a pericardiocentesis.Blood was still collecting in the pericardial space.Cardiovascular surgery was consulted.Emergent surgery was needed to stop the bleeding.It was noted the patient was on plavix at the time of the procedure.There were no further complications.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24913673
• Report Number: 2124215-2026-21014
• Device Sequence Number: 18591858
• Product Code: NGV
• UDI-Device Identifier: 00191506004637
• UDI-Public: (01)00191506004637(17)290127(10)38457357
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: M635WU60400
• Device Catalogue Number: M635WU60400
• Device Lot Number: 0038457357
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 01/28/2026
• 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: 81 YR
• Patient Sex: Female