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

Model Number	M635WU24060
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event - aware date used as event date is unknown.
Event or Problem Description
It was reported that device embolization occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 24mm watchman flx laa closure device & delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted in the laa of the patient.There were no patient complications that were reported to have occurred.Five (5) years post procedure it was discovered that the closure device had embolized out of the laa.The closure device was found in the descending aorta and blocking the renal arteries.An interventional radiologist successfully removed the closure device from the patient percutaneously.There were no other complications that were reported to have occurred as a result of this event.

• 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: 22853470
• Report Number: 2124215-2025-57620
• Device Sequence Number: 8457611
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: (01)08714729838234(17)230116(10)25058928
• 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: 2020
• 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): 08/20/2025

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: 01/16/2023
• Device Model Number: M635WU24060
• Device Catalogue Number: M635WU24060
• Device Lot Number: 0025058928
• 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: 08/13/2025
• Initial Report FDA Received Date: 08/20/2025
• Date Device Manufactured: 01/17/2020
• 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: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Unknown