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

Model Number	M635WU60350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device embolization occurred.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx pro closure device was selected to be used.This was a concomitant procedure.After ablation was completed, the physician began with the closure device procedure.The ablation sheath was exchanged for transeptal.The pigtail catheter was advanced into the laa and a contrast picture was taken.The left atrium pressure was ten (10).The rhythm at the time of the implant of the closure device was normal sinus.A 35mm closure device was prepped and deployed.Initially the closure device was too proximal and multiple recaptures were performed.After last deployment, the position appears acceptable and the position, anchor, size and seal (pass) criteria were met.Post release it was noted a proximal shift in the closure device, attempts were made to rescrew the closure device but were unsuccessful.The decision was made to attempt retrieval, during this time, the closure device had shifted even more.As the physician gathered retrieval equipment, safari wire and amplatz super stiff were inserted into the left atrium to exchange for a non-boston scientific (bsc) 23fr micra sheath.It was noted the closure device shifted into the mitral valve.At this time retrieval was abandoned, as to not cause harm to mitral leaflets and the patient was taken to the operating room (or).The closure device was retrieved, the laa was clipped and a mitral ring was inserted.The patient remains stable in the intensive care unit (icu).

• 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: 50777877
• Report Number: 2124215-2026-49227
• Device Sequence Number: 10754274
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• 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: M635WU60350
• Device Catalogue Number: M635WU60350
• Device Lot Number: 0039063320
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 04/12/2026
• 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: 70 YR
• Patient Sex: Male