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 Code	Thrombosis/Thrombus (4440)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman trusteer access system (was) and a watchman laa closure device & delivery system (wds) were selected for use.The physician advanced the trusteer sheath and pigtail catheter into the appendage.An activated clotting time (act) measurement of 139 seconds was obtained.The physician paused to check act, this time measuring 143 seconds, and another 10,000 units of heparin was administered.The pigtail was removed from the trusteer sheath.As the pigtail catheter was removed from the patient's body, clots were noted on the pigtail catheter.The physician replaced the old trusteer for a new one.Act was measured and it was over 400 seconds.Physician proceeded with the implant procedure and a closure device was successfully implanted in the laa.

• 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: 50791024
• Report Number: 2124215-2026-49453
• Device Sequence Number: 21186185
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/16/2026

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: 0039757196
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/16/2026
• 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: Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 138 LB