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

Model Number	M635WU30060
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via watchman patient call center.It was reported that the device did not seal, and a transient ischemic attack (tia) occurred.A left atrial appendage closure procedure was performed on (b)(6) 2019, and a 30mm watchman laa closure device was implanted.It was reported to boston scientific (bsc) on (b)(6) 2025, that the patient had experienced a tia five to six months ago.While being treated for the tia, imaging revealed the closure device was not sealing the laa and in response, the physicians placed the patient back on a medication regimen.No further details were made available.
Additional Manufacturer Narrative
B3: bsc aware date used as event date, as it is unknown.Procedure physician name: (b)(6).Primary or referring physician name: (b)(6).Facility name: (b)(6).Facility city: (b)(6).Facility state: (b)(6).

• 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: 21470743
• Report Number: 2124215-2025-11502
• Device Sequence Number: 14365717
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: M635WU30060
• Device Catalogue Number: M635WU30060
• Device Lot Number: 0022442883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 07/30/2018
• 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: 74 YR
• Patient Sex: Male