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 Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed, and a watchman fxd curve access system (was) was selected to be used.During the procedure, access was obtained via the groin for the was sheath and an additional sheath for intra cardiac echocardiography (ice).Versacross connect was used in conjunction with ice to cross the atrial septum at an inferior-mid location.The wire crossed the septum, and position was confirmed by ice without issue.The was sheath was advanced and retracted to dilate septal puncture.The ice catheter was advanced across the septum uneventfully and measurements of the laa were obtained.The was sheath was advanced to the left atrium, a pigtail catheter was inserted and an angiogram was performed.The patient's blood pressure was low, so an effusion sweep was performed with ice, and a large pericardial effusion was noted on the right ventricle (rv) free wall.The patient's chest was prepped and pericardiocentesis was performed.A total of 400cc of bright red blood was aspirated, and the patient required one (1) unit of blood transfusion.The sheaths were removed and the patient was intubated and transferred to the intensive care unit (icu).The patient had been discharged from the hospital.

• 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: 50671278
• Report Number: 2124215-2026-47821
• Device Sequence Number: 9272778
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/30/2026

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: 0038725236
• 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: 08/25/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/30/2026
• 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; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female