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

Model Number	M635WU60350
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device migration and a stroke occurred.A concomitant procedure consisting of pulse field ablation and left atrial appendage closure (laac) was performed.Following completion of the ablation procedure, a watchman truseal access system (was) and a 35mm watchman flx pro left atrial appendage (laa) closure device and delivery system (wds) were selected for the laac procedure.The wds was advanced into the laa and deployed.Prior to release, the device position and compression were assessed and deemed acceptable.Following release, the closure device appeared to shift to a more proximal position compared with its pre-release location.Although the device remained within the laa, it was noted to be seated relatively proximally.The patient remained under observation following implantation.Subsequently, the patient developed symptoms for a stroke.Magnetic resonance imaging (mri) was performed as part of the post-procedural evaluation.

• 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: 50601428
• Report Number: 2124215-2026-45864
• Device Sequence Number: 21475318
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• UDI-Public: (01)00191506004620(17)280421(10)36341980
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 0036341980
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 04/22/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97423085-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 154 LB