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 Codes	Nonstandard Device (1420); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device shift occurred.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx closure device was implanted on (b)(6) 2024.The patient was discharged.At the routine 45-day follow-up, computed tomography imaging revealed the device had shifted.No intervention was performed and there were no patient complications.Upon analysis, it was found that the ct imaging showed crossed tines and the device puck in the center of the device, indicating a device fracture due to axial compression of the device in its current position.
Additional Manufacturer Narrative
B3 date of event: event date estimated as (b)(6) 2024 as the event was reported to have occurred at the 45 day follow up after implant date of (b)(6) 2024.Media was provided and evaluated by members of the bsc training team, medical safety, and clinical specialists.The media review concluded that the patient anatomy had a large distal volume, which may have led to low compression and poor anchor engagement, causing the position to shift into the laa upon core wire release.No indication of use error.Additional observation: ct imaging shows crossed tines and the device puck in the center of the device, indicating a device fracture due to axial compression of the device in its current position.

• 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: 24499694
• Report Number: 2124215-2026-11727
• Device Sequence Number: 13290811
• Product Code: NGV
• UDI-Device Identifier: 08714729860525
• UDI-Public: (01)08714729860525(17)260723(10)32073386
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2026
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0032073386
• 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: 07/31/2024
• Initial Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 07/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male