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

Model Number	10390
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: event date was approximated to 07/01/2024 since per email, the imaging was done (b)(6) 2024.
Event or Problem Description
Reported via patient call center.It was reported a device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 27 mm watchman flx pro closure device was implanted on (b)(6) 2024.The patient was subsequently discharged.In (b)(6) 2024, the patient contacted the watchman call center and reported that a computed tomography angiography (cta) showed a 13mm peri-device leak.However, cardiology reviewed the imaging and determined the leak measured less than 4mm.The patient also reported experiencing visual auras beginning postoperatively in 2024.In (b)(6) 2025, the patient underwent closure of an atrial septal defect/patent foramen ovale (asd/pfo), but the visual auras persisted.At a follow-up visit in late (b)(6) 2026, a cta demonstrated a 6mm x 15mm superior peri-device leak, which radiology noted was unchanged from the 2024 imaging.The patient reported that cardiology advised that the leak now requires intervention.

• Brand Name: WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
• 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: 25232059
• Report Number: 2124215-2026-27190
• Device Sequence Number: 16041630
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)261112(10)32841053
• 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: 2024
• 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): 05/20/2026

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 Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0032841053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 11/13/2023
• 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: 77 YR
• Patient Sex: Female