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	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a circumferential pericardial effusion, cardiac tamponade and cardiac perforation occurred.A left atrial appendage closure (laac) procedure was being performed.A watchman trusteer access system (was) was selected for use.A small baseline effusion was noted in the transverse sinus adjacent and deep to the laa just before the procedure.The initial transeptal puncture (tsp) was performed.The physician inserted the trusteer sheath and parked it inside the laa.Using transesophageal echocardiography (tee), a small amount of fluid in the transverse sinus and in the laa was noted.The physician inserted the pigtail catheter.Using fluoroscopy, it was noted the pigtail catheter jumped outside of the sheath.Using tee, it was noted contrast filling in the transverse sinus/pericardium.At this time, the patient's vitals were noted, and the patient became hypotensive and tachycardic.The physician performed pericardiocentesis, draining approximately 1300ml of dull red colored blood from the pericardium, transfusing it back to the patient.The patient went into ventricular tachycardia and cardioversion was implemented.A pericardial drain was inserted, and the patient was transferred to the operating room where a pericardial window was performed.A large 2-3cm circumferential pericardial effusion was noted.It was also noted the perforation occurred in the distal laa, and as a result the laa was ligated and clipped.Patient stabilized and was hospitalized beyond standard of care.

• 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: 50818291
• Report Number: 2124215-2026-49928
• Device Sequence Number: 13431339
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• UDI-Public: (01)00191506022310(17)280513(10)39337723
• 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): 09/18/2026

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: 0039337723
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/14/2026
• 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; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female