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	Non specific EKG/ECG Changes (1817); Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced st segment elevation.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 performed the transseptal puncture and positioned the was in the la of the patient.It was at this time that the patient's ecg showed st segment elevation.No air was visualized on fluoroscopy when the pigtail catheter was advanced.The procedure was paused at this time to monitor the patient.There were no changes to any other vital signs and anesthesia did not need to alter their support to the patient.The st segment elevation resolved on its own after about 4 minutes.La pressure was recorded, contrast image was taken of the laa, final decision on device size was made, device was prepped, advanced and deployed.After two (2) full recaptures were performed the closure device was able to be successfully implanted in the laa of the patient.All the devices were removed from the patient.The physician was unable to control the bleeding at the groin site.Surgery was requested to scrub in and evaluated the groin site bleeding.Surgery did end up cutting down on the groin to internally suture and close the venous vessels.There were no other complications that were reported to have occurred.The patient was admitted overnight for observation and discharged to home the following day without complications.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50054023
• Report Number: 2124215-2026-40272
• Device Sequence Number: 13420812
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: (01)00191506013813(17)290131(10)38489999
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2026

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: 0038489999
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 08/12/2026; Not provided
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/13/2026; 09/04/2026
• Date Device Manufactured: 02/01/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97423085-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Female