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); 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 cardiac perforation and pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed concomitantly with an ablation procedure.After the ablation was completed, the sheath was smoothly exchanged for a watchman trusteer access system (was).The physician inserted a pigtail catheter into the laa and advanced using fluoroscopy due to not having visualization on intracardiac echo (ice).The was continued to be advanced up to the ostium.An appendagram was taken, but visualization was difficult, so the physician completed another contrast shot.The result was the same.The patient's blood pressure began to drop into the middle 70s systolic over 60 diastolic.An effusion check was completed, and an effusion was noted in the laa.The patient remained stable and the electrocardiogram (ekg) remained the same.The physician spent additional time repositioning the was before discontinuing the procedure and addressing the effusion.The physician performed a pericardiocentesis and removed 400cc of bright red blood.An unknown amount of blood was re-transfused back into the patient.The bleeding continued and the physician realized the appendage had been perforated.The patient was taken to the operating room and the appendage was clipped.The patient is scheduled for discharge.

• 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: 50372479
• Report Number: 2124215-2026-45113
• Device Sequence Number: 5714733
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/24/2026

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: 0039414454
• 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: 09/23/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 05/24/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Male