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	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.The physician was attempting to go transeptal and noticed a small pericardial effusion.The physician had slipped into the coronary sinus with the pigtail catheter.The patient was given protamine and the effusion remained stable.The procedure was discontinued.The patient was monitored and will have follow up echocardiography imaging to evaluate for effusion.
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.The physician was attempting to go transeptal and noticed a small pericardial effusion.The physician had slipped into the coronary sinus with the pigtail catheter.The patient was given protamine and the effusion remained stable.The procedure was discontinued.The patient was monitored and will have follow up echocardiography imaging to evaluate for effusion.
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage closure (laac) procedure was being performed.The physician was attempting to go transeptal and noticed a small pericardial effusion.The physician had slipped into the coronary sinus with the pigtail catheter.The patient was given protamine and the effusion remained stable.The procedure was discontinued.The patient was monitored and will have follow up echocardiography imaging to evaluate for effusion.
Additional Manufacturer Narrative
D4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H6: patient codes - updated.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis: the watchman fxd curve? access system was discarded; therefore, returned device analysis could not be completed.Device history record review: a review was completed of the device history records (dhr) for the watchman fxd curve? access system, part # m635tu80020 batch # 0038803442.The dhr review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman fxd curve? access system instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include pericardial effusion and cardiac perforation.Risk review: a risk review was completed and confirmed that the events of pericardial effusion and cardiac perforation were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• 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: 50229887
• Report Number: 2124215-2026-43378
• Device Sequence Number: 10256696
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: (01)00191506013813(17)290309(10)38803442
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 09/28/2026

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: 0038803442
• 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: 08/07/2026
• Supplement Date Received by Manufacturer: Not provided; 09/15/2026; 09/23/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 08/19/2026; 09/21/2026; 09/28/2026
• Date Device Manufactured: 03/10/2026
• 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: 69 YR
• Patient Sex: Male