MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FXD Curve? Access System; system, appendage closure, left atrial

Model Number	M635TU80020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a perforation occurred.A left atrial appendage closure (laac) procedure was being performed.It was noted that the patient had a trace baseline pericardial effusion prior to the procedure.A watchman fxd double curve access system (was) and a 27mm watchman flx pro laa closure device and delivery system (wds) was selected for use.The physician was advancing the 27mm wds through the was sheath, and as the device approached the distal marker, the was sheath lifted to the anterior side of the ridge.The physician suspected the was sheath may have perforated a small portion of the ridge on the limbus side of the appendage, near the ostium, although this was not confirmed via imaging.There was no clinical effect, and the baseline effusion did not show a notable difference.The closure device was successfully implanted, and the suspected perforation site was covered by the watchman closure device.There were no patient complications, and the patient was discharged the next day.

• Brand Name: WATCHMAN FXD Curve? Access System
• 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: 50143177
• Report Number: 2124215-2026-41916
• Device Sequence Number: 10657050
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: (01)00191506013813(17)290103(10)38260048
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M635TU80020
• Device Catalogue Number: M635TU80020
• Device Lot Number: 0038260048
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 01/04/2026
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Female