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); Pericardial Effusion (3271)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.A watchman fxd curve access system (was) and a 20mm watchman flx pro closure device and delivery system (wds) were initially selected for use.The transeptal puncture (tsp) was difficult to cross the septum due to the septal orientation, and the presence of defibrillation leads in the right atrium.After two attempts, the physician used a different versacross system and exchanged for the was sheath after crossing.Pericardial effusion was noted post tsp, so the physicians monitored it throughout the procedure.The physician unsuccessfully attempted to place the intracardiac echo (ice) probe in the la.Contrast was shot into the laa and the device sizing was determined.The 20mm device was placed into the laa and rejected for sizing.A 24mm device was then selected.After two full recaptures, the physician determined the device was placed properly based on the tug test and contrast shot.Full position, anchor, size and seal (pass) criteria were not used due to ice remaining in the right atrium.After the wds was removed, ice was brought to the left side for final imaging through the was sheath.During closure, the patient's blood pressure dropped.Transesophageal echocardiography (tee) imaging was completed and showed an increase in size of the effusion.A pericardiocentesis was performed and 600cc of dull colored fluid was removed.Additional units of blood were transfused back into the patient.The patient was kept overnight for observation.

• 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 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25893256
• Report Number: 2124215-2026-39216
• Device Sequence Number: 15987802
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: (01)00191506013813(17)290111(10)38322434
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/15/2026

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: 0038322434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 01/12/2026
• 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: 84 YR
• Patient Sex: Male