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

Model Number	M635WU60240
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a device embolization occurred.A left atrial appendage (laa) closure procedure was performed, and a 24mm watchman flx pro closure device was successfully implanted.The patient was discharged.During patient's routine 45-day transesophageal echocardiogram (tee) imaging, it was noted the closure device was not in the laa.Radiograph (x-ray) imaging located the closure device in the patient's aorta.The patient was scheduled for device retrieval.The embolized closure device was percutaneously retrieved via 16 f cook dryseal sheath and rescue alligator grasping forceps without any incident.There are no current plans for reimplantation.There were no further complications and the patient remained in the hospital for approximately three days post procedure before being discharged.

• 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: 50602448
• Report Number: 2124215-2026-47185
• Device Sequence Number: 18784955
• Product Code: NGV
• UDI-Device Identifier: 00191506004590
• UDI-Public: (01)00191506004590(17)290225(10)38695938
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: M635WU60240
• Device Catalogue Number: M635WU60240
• Device Lot Number: 0038695938
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 02/26/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 173 LB