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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device shift and explant occurred.A concomitant ablation and left atrial appendage closure procedure was being performed.Watchman sizing was determined prior to ablation; the workup suggested a 35-40mm sized watchman flx pro closure device.Intracardiac echocardiogram (ice) imaging measured 22-28mm.The ablation was performed successfully with a non-boston scientific (bsc) pulse field ablation device.Afterwards, the sheath was exchanged for a watchman trusteer access system.The physician selected a 35mm watchman flx pro closure device.After two partial re-captures, the closure device was successfully implanted.Release criteria were met with 25-31% compression, the tug test was stable, and the position was acceptable at the level of the ostium.After full release, the closure device shifted.The physician deemed explant necessary.A 22fr non-bsc sheath was inserted along with non-bsc biopsy forceps for removal of the closure device from the appendage.The patient remained stable with no adverse events.The physician felt re-implant was not appropriate at this time.

• 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: 50100610
• Report Number: 2124215-2026-41268
• Device Sequence Number: 10368656
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• UDI-Public: (01)00191506004620(17)290311(10)38813796
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/09/2026

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: 0038813796
• 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: 07/28/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 03/12/2026
• 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: 66 YR
• Patient Sex: Male