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

Model Number	M635WU60270
Medical Device Problem Codes	Migration (4003); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device shift and device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 27mm watchman flx pro closure device was implanted on (b)(6) 2026.The patient was discharged.On (b)(6) 2026, the patient presented for a routine follow-up transesophageal echocardiography (tee), during which it was noted that the closure device had shifted, although it appeared stable.To further evaluate the finding, a computed tomography (ct) scan was obtained on (b)(6) 2026, which confirmed proximal closure device migration.Upon retrospective review of the follow-up tee, color doppler imaging demonstrated a leak on the ridge side, with no remaining fabric coverage.Following discussion with the physician, the decision was made to proceed with closure device explantation.The patient will resume anticoagulation therapy until the procedure.The planned retrieval strategy includes the use of a non-boston scientific (bsc) retrieval device, a grasping device, and a watchman trusteer access system (was) sheath.If the patient remains clinically stable and anatomy is suitable, a replacement closure device will be implanted during the same procedure, with the closure device size to be determined at the time of implantation.On (b)(6) 2026, the closure device was removed, and another closure device was reimplanted.

• 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: 50692009
• Report Number: 2124215-2026-48146
• Device Sequence Number: 5927824
• Product Code: NGV
• UDI-Device Identifier: 00191506004606
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/30/2026

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: M635WU60270
• Device Catalogue Number: M635WU60270
• Device Lot Number: 0039218565
• 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: 08/20/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/29/2026
• 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: Required Intervention; Other
• Patient Sex: Male