MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX? Pro; system, appendage closure, left atrial

Model Number	M635WU60310
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device shift occurred.A left atrial appendage (laa) closure procedure was performed, and a 31mm watchman flx pro closure device was implanted on (b)(6) 2025.The patient was discharged.On (b)(6) 2026, the patient was scheduled for an atrial fibrillation (af) ablation to be performed by an electrophysiology (ep) cardiologist in the ep laboratory.The patient underwent general anesthesia for this procedure.The ep cardiologist performed transesophageal echocardiography (tee) to rule out clot for the af ablation, and it was discovered that the closure device was under compressed, had shifted and was not in the position of release.The ep cardiologist consulted the physician who performed the closure device procedure and had the physician observe the closure device on tee.The physician noted that the closure device was not completely in the appendage and appeared to have been shifted from the time of implant.Both physicians discussed to have the patient wake up from general anesthesia and to not have the af ablation performed that day and discuss further options of the closure device.The physician asked the watchman team to evaluate the computed tomography (ct) of the closure device and send for further evaluation.The team discovered the closure device had shifted from implant and reported this back to the physician, discussed with the cardiothoracic (ct) surgeons about further options and the result was to have the closure device extracted in the operating room (or).The physician assisted the ct surgeons on (b)(6) 2026 and extracted the closure device and the appendage was ligated.

• Brand Name: WATCHMAN FLX? Pro
• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50773281
• Report Number: 2124215-2026-49119
• Device Sequence Number: 21200195
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635WU60310
• Device Catalogue Number: M635WU60310
• Device Lot Number: 0035168005
• 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: 07/22/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 10/29/2024
• 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: 68 YR
• Patient Sex: Female