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 Perforation (2513)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a cardiac perforation occurred.A left atrial appendage closure (laac) procedure was being performed.A watchman fxd double curve access system (was) and a watchman laa closure device & delivery system (wds) were selected for use.After achieving femoral access, a transseptal puncture (tsp) was performed.As physician attempted to access the left superior pulmonary vein (lspv), the 5 fr angled pigtail catheter was difficult to insert into the ostium, and switched out for a 4 fr mtaka catheter.Using a guidewire to access the anterior lobe, contrast imaging was used to improve visualization.Faint contrast flow was observed from the anterior lobe into the left atrium, where it pooled, when physician suspected a perforation had occurred.Transesophageal echocardiography (tee) and transthoracic echocardiogram (tte) were performed and there was no pericardial effusion observed.Patient's blood pressure dropped and norepinephrine was administered to increase pressure.Following a period of observation, the procedure resumed, implanting the closure device.Tee and tte were performed a second time, and there was no increase in pericardial fluid noted.The patient remained in stable condition and was transferred to the intensive care unit (icu) for recovery.The physician suspected there could be damage to the left atrial appendage caused by manipulation of the guidewire or mtaka.Anticoagulant therapy was scheduled to be resumed the following day.

• 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: 50173896
• Report Number: 2124215-2026-42377
• Device Sequence Number: 15514670
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: (01)00191506013813(17)290121(10)38416905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: 0038416905
• 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: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 01/22/2026
• 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: 80 YR
• Patient Sex: Male