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

Model Number	M635WU50240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed, and a 24mm watchman flx delivery system (wds) was successfully implanted on (b)(6) 2023.The patient was discharged.A transesophageal echocardiogram (tee) was performed to evaluate the left atrial appendage prior to the ablation and a clot was noted attached to the outer edge of the closure device.The case was cancelled due to risk of dislodging the clot.There were no patient complications.They plan to bring the patient back at a later date and hope the clot has cleared.There was no further information at the time of this report.

• Brand Name: WATCHMAN FLX?
• 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: 22699796
• Report Number: 2124215-2025-53578
• Device Sequence Number: 18360259
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)260611(10)31798446
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: 06/11/2026
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0031798446
• 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: 07/15/2025
• Initial Report FDA Received Date: 08/04/2025
• Date Device Manufactured: 06/12/2023
• 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: Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 62 KG