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 Codes	Balance Problems (4401); Diplopia/Double Vision (4802)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device migration occurred.A left atrial appendage closure (laac) procedure was performed on (b)(6) 2026, and a 31mm watchman flx pro laa closure device was implanted as part of a concomitant ablation procedure.Despite having challenging anatomy, only one deployment was needed.There were no full or partial recaptures.The patient was discharged.The patient went in for an emergent follow up with episodes of double vision and loss of balance on (b)(6) 2026, and echocardiography imaging was performed.The device was discovered to have shifted and had partially embolized out of the laa.A decision was made to explant the device.The patient was adamant that a new closure device be implanted.The canted device was successfully percutaneously explanted, and a new device was implanted.The patient was reported to be in stable condition following the procedure.

• 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: 50803049
• Report Number: 2124215-2026-49656
• Device Sequence Number: 13399004
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 09/17/2026

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: 0039077884
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/14/2026
• 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
• Patient Age: 66 YR
• Patient Sex: Male