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	Atrial Fibrillation (1729); High Blood Pressure/ Hypertension (1908); Pericardial Effusion (3271)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed, and a watchman trusteer access system (was) was selected to be used.The patient had a windsock anatomy with posterior bend.During the procedure the physician performed transseptal puncture with the was and a pigtail catheter.The pigtail catheter was advanced into the appendage and removed for closure device insertion.During transesophageal echocardiography (tee) monitoring the physician noted more fluid being present around the appendage and was concerned for a pericardial effusion.The implanting physician placed the procedure on hold and had imaging physician sweep for size of effusion present.The effusion was seen around the left ventricle (lv) measuring one (1) cm in diameter, the patient was in atrial fibrillation (af) with heart rate elevated to about 100 bpm for the entire case, and the blood pressure (bp) was elevated to about 170/80.The physician determined to abort procedure due to uncertainty of post-operation care.The patient was monitored with tee for 20 minutes where vitals stabilized, the patient went into sinus rhythm, and the effusion never increased in size.After this time, the physician decided to close and did not administrate protamine.
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed, and a watchman trusteer access system (was) was selected to be used.The patient had a windsock anatomy with posterior bend.During the procedure the physician performed transseptal puncture with the was and a pigtail catheter.The pigtail catheter was advanced into the appendage and removed for closure device insertion.During transesophageal echocardiography (tee) monitoring the physician noted more fluid being present around the appendage and was concerned for a pericardial effusion.The implanting physician placed the procedure on hold and had imaging physician sweep for size of effusion present.The effusion was seen around the left ventricle (lv) measuring one (1) cm in diameter, the patient was in atrial fibrillation (af) with heart rate elevated to about 100 bpm for the entire case, and the blood pressure (bp) was elevated to about 170/80.The physician determined to abort procedure due to uncertainty of post-operation care.The patient was monitored with tee for 20 minutes where vitals stabilized, the patient went into sinus rhythm, and the effusion never increased in size.After this time, the physician decided to close and did not administrate protamine.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis the watchman trusteer? access system was discarded; therefore, returned device analysis could not be completed.Device history record review a review was completed of the device history records (dhr) for the watchman trusteer? access system, part # m635tu90050 batch # 0038614477.The dhr review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman trusteer? access system instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include pericardial effusion and arrhythmias (atrial fibrillation).Risk review a risk review was completed and confirmed that the events of pericardial effusion and arrhythmias (atrial fibrillation) were defined in the risk documentation.Thes event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• 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: 50349135
• Report Number: 2124215-2026-44863
• Device Sequence Number: 14962280
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 0038614477
• 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: 09/22/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 02/16/2026
• 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
• Patient Sex: Female