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

Model Number	M635WU21060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via patient call center.It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device was implanted on (b)(6) 2020.The patient stated that he had problems with watchman before, stated the closure device opened prematurely and nicked the sack around the heart.The patient stated that he was bleeding out and require emergency surgery.A good faith effort (gfe) was performed and the nurse practitioner (np) reported that a small pericardial effusion was noted on (b)(6) 2020 following the implant procedure.The patient had a repeat echocardiogram on (b)(6) 2020, and it was confirmed the effusion was stable.On (b)(6) 2020, the patient experienced shortness of breath, and on (b)(6) 2020, the patient underwent pericardiocentesis and 500ml of fluid were removed after a previously stable pericardial effusion (pe) progressed to borderline cardiac tamponade.The drain was removed on (b)(6) 2020, and the patient was discharged on (b)(6) 2020.The patient had a follow up on (b)(6) 2020, and the patient was noted to be in good health and oral anticoagulation (oac) therapy was resumed.The patient continues to be in good health and is currently maintained on 81mg of aspirin.

• Brand Name: WATCHMAN
• 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: 22815137
• Report Number: 2124215-2025-56699
• Device Sequence Number: 12203893
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: (01)08714729838227(17)230128(10)25125661
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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 Expiration Date: 01/28/2023
• Device Model Number: M635WU21060
• Device Catalogue Number: M635WU21060
• Device Lot Number: 0025125661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/15/2025
• Date Device Manufactured: 01/29/2020
• 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