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); Perforation of Vessels (2135)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a vessel perforation occurred.The patient underwent a concomitant pulse field ablation (pfa) and a left atrial appendage (laa) closure procedure.The physician gained venous access and proceeded with the concomitant procedure.The concomitant procedure was successfully completed.A watchman trusteer access system (was) and a watchman flx pro laa closure device & delivery system (wds) were selected to be used.The physician inserted the was in the patient, and the right femoral vein was perforated.The procedure was continued and the closure device was successfully implanted.The patients' blood pressure dropped after removing the was from the patient.The patient had a stent placed to repair the artery that was perforated.There was no other treatment or intervention performed for the patient.No other complications were reported to have occurred as a result of this event.The patient is expected to make a full recovery.
Event or Problem Description
It was reported that a vessel perforation occurred.The patient underwent a concomitant pulse field ablation (pfa) and a left atrial appendage (laa) closure procedure.The physician gained venous access and proceeded with the concomitant procedure.The concomitant procedure was successfully completed.A watchman trusteer access system (was) and a watchman flx pro laa closure device & delivery system (wds) were selected to be used.The physician inserted the was in the patient, and the right femoral vein was perforated.The procedure was continued and the closure device was successfully implanted.The patients' blood pressure dropped after removing the was from the patient.The patient had a stent placed to repair the artery that was perforated.There was no other treatment or intervention performed for the patient.No other complications were reported to have occurred as a result of this event.The patient is expected to make a full recovery.
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 # 0039066062.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 valvular/vascular damage (vessel perforation) and hypotension.Risk review.A risk review was completed and confirmed that the events of valvular/vascular damage (vessel perforation) and hypotension were defined in the risk documentation.These 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: 50329780
• Report Number: 2124215-2026-44680
• Device Sequence Number: 5468557
• Product Code: DQY
• UDI-Device Identifier: 00191506022310
• UDI-Public: (01)00191506022310(17)280412(10)39066062
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/25/2026

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: 0039066062
• 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: 08/19/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 04/13/2026
• 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: 79 YR
• Patient Sex: Male