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	Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion, chest pain, hypotension and thrombosis occurred.A left atrial appendage closure (laac) procedure was being performed.Prior to the procedure, the patient was known to have a patent foramen ovale (pfo), an extremely aneurysmal septum and difficult anatomy with a rotated heart.A watchman trusteer access system (was) was selected for use.It was decided to cross the septum above the pfo, rather than through.When attempting to advance versacross looped wire up the superior vena cava (svc), the wire and sheath kept advancing through the pfo rather than up the svc.Suboptimal imaging was a concern throughout the case.The physician was unable to visualize the sheath, wire and appendage on transesophageal echocardiography (tee).A sweep was attempted to find the sheath and the wire.The sheath had crossed above the pfo.The sheath was riding parallel alongside the top of the aorta, but the end of the sheath and wire could not be seen on tee.There was concern that the pericardial space had been crossed.Pericardial fluid was aspirated and the pigtail was withdrawn slightly.Blood was aspirated from the pigtail.Vitals were monitored while an effusion check was completed.No effusion was found and the vitals were stable.There was a concern about withdrawing the sheath if a structure of the heart had indeed been punctured, but the physician decided to proceed.There were still no signs of effusion, and the patient vitals were stable.The septum was crossed above the pfo with a verscross connect.Once in the left atrium, a large clot was noted on tee.The clot looked like it was flopping around in the la and looked like it was attached to the mitral annulus.Because the effusion took some time to show up it is likely that aorta was not punctured but instead may have been skimmed when the initial images were difficult.The physician decided to discontinue the procedure and aspirated from and slowly withdrew the sheath.No clot was found on the sheath.Patient vitals remained stable.A small marginal effusion was found on the tee at the end of the case, but no changes were seen for 20-30 minutes.One to two hours following the procedure, the patient experienced chest pain and had a drop in blood pressure.Tee was completed and the effusion had grown.The patient was brought back for a pericardiocentesis where 730ml of blood was removed.The patient was kept overnight on a heparin drip to monitor the effusion.The patient was reported to be in stable condition.

• 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: 50602403
• Report Number: 2124215-2026-45828
• Device Sequence Number: 10634175
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• UDI-Public: (01)00191506022310(17)271118(10)37990235
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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
• Report Date (Section B): 10/02/2026

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: 0037990235
• 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: 10/01/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 11/18/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown