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	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion, cardiac tamponade and cardiac perforation occurred.A left atrial appendage (laa) closure procedure was being performed, and a watchman trusteer access system (was) was selected to be used.During the procedure, while exchanging for a larger closure device, the exchange was performed without using a pigtail catheter.The clinical suggested re-advancing a pigtail catheter to facilitate safe sheath positioning.During the pigtail loading with the wire, the wire appeared to be in the pericardium.An effusion sweep was performed during the loading of the 24mm closure device, and a pericardial effusion was noted.The 24mm closure device was deployed safely, and met position, anchor, size and seal (pass) criteria.Before releasing the closure device, a contrast shot was performed, raising concern for a perforation on the ridge side.The closure device was subsequently released, equipment was moved to the left side, and protamine was administered.The physician attempted to performed pericardiocentesis but was unsuccessful.A pericardial window procedure was then performed and additional blood was required.The patient was stable when transferred to the intensive care unit (icu).

• 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: 50376439
• Report Number: 2124215-2026-45174
• Device Sequence Number: 5714854
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• UDI-Public: (01)00191506022310(17)280326(10)38944943
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 0038944943
• 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: 09/19/2026; 09/29/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/22/2026; 09/30/2026
• Date Device Manufactured: 03/27/2026
• 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; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male