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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via patient call center.It was reported that the device did not seal.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 30 mm watchman laa closure device and 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.The patient came in for their 45 day follow up imaging procedure.The imaging showed that there was a 5 mm leak present.The patient remained on their eliquis medication in response to this event.Five (5) years post procedure the patient underwent a procedure to plug the leak.The procedure was unsuccessful as the coils could not be placed.The patient remains on their eliquis medication.There were no other complications that were reported to have occurred.

• 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: 21909870
• Report Number: 2124215-2025-26123
• Device Sequence Number: 18341718
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: (01)08714729838258(17)220305(10)23448347
• 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): 04/25/2025

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: 03/05/2022
• Device Model Number: M635WU30060
• Device Catalogue Number: M635WU30060
• Device Lot Number: 0023448347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/25/2025
• Date Device Manufactured: 03/06/2019
• 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: 78 YR
• Patient Sex: Male