MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TruSteer? Access System; Catheter, percutaneous

Model Number	M635TU90050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Perforation of Vessels (2135)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an st segment elevation.The patient underwent a concomitant pulse field ablation (pfa) and a left atrial appendage (laa) closure procedure.The physician gained venous access and proceeded with the concomitant procedure.The ablation procedure was successfully completed.A watchman trusteer access system (was) and a watchman flx pro laa closure device & delivery system (wds) were selected to be used.The physician inserted the was and imaging showed that the was was on the mitral valve.The physician then advanced the was into the laa, and it was noted that the patient was experiencing an st segment elevation.No air was seen in the patient or any device.The procedure was continued and the closure device was successfully implanted in the laa of the patient.After the device was implanted it was noted that the patients vitals were getting better.Another physician came in to do a heart catheterization and those images were clean.The physician believes that they may have minorly injured the circumflex artery when they flipped the was from the mitral valve into the laa and that the minor injury was already settling down by the time the procedure had been completed.There were no other complications that were reported to have occurred as a result of this event.

• Brand Name: WATCHMAN TruSteer? Access System
• Common Device Name: Catheter, percutaneous
• 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: 50802181
• Report Number: 2124215-2026-49629
• Device Sequence Number: 15614359
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K240018
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: M635TU90050
• Device Catalogue Number: M635TU90050
• Device Lot Number: 0039758757
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 07/08/2026
• 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: 66 YR
• Patient Sex: Unknown