MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FXD Curve? Access System; system, appendage closure, left atrial

Model Number	M635TU80020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a perforation.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a watchman flx pro laa closure device & delivery system (wds) were selected to be used.The physician had some difficulty performing the transseptal puncture.The physician had to rewire up the superior vena cava a few times due to a narrow septal opening before being able to cross.The was and versacross connect wire both went across without excessive force.Fluoroscopy showed that the devices were seated in the pulmonary vein, but this was hard to tell via transesophageal echocardiogram (tee).The physician tried getting into the laa and continued to have difficulty.A contrast shot was performed, and the physician tried to pull back blood but was unable to.The physician was finally able to track that the was in the pericardium.The ct surgeon also agreed it was hard to determine the positioning of the was.The patient was then brought up to the operating room to be further evaluated.A sternotomy was performed where the patient was stitched and had their appendage clipped.There were no other complications that were reported to have occurred, and the patient is expected to make a full recovery.

• Brand Name: WATCHMAN FXD Curve? Access System
• Common Device Name: system, appendage closure, left atrial
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; multitenant #2, street #58 zon; cartago, 03 30106 ; EI 30106
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50174133
• Report Number: 2124215-2026-42385
• Device Sequence Number: 10035532
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• 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): 09/23/2026

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: M635TU80020
• Device Catalogue Number: M635TU80020
• Device Lot Number: 0038725580
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 03/02/2026
• 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: 74 YR
• Patient Sex: Female