MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FXD CURVE? ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635TU80010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a 27mm watchman flx laa closure device & delivery system (wds) were selected to be used.The physician positioned the was in the laa of the patient and then inserted the wds.The 27mm closure device was noted to be too large for the appendage, a 24mm closure device was opened and inserted.While this closure device fit the appendage it was noted that there was at least 1/2 of a mitral shoulder and the physician decided to attempt a 20mm device.The 24mm device was removed and the pigtail wire was reinserted into the appendage to gain the required depth for deployment.The 20mm was prepped appropriately and the pigtail was then removed.It was noted at this time that the was appeared to dive deeper into the appendage.The 20mm closure device was inserted and a contrast injection was performed.During the contrast injection it was noted that contrast was filling into the pericardium.The 20mm closure device was left in the appendage while a pericardiocentesis was performed which removed 600ml of fluid.When the patient was stable the 20mm device was deployed into the appendage.The patient continued to bleed into the pericardium, and it was decided that they would need further intervention.The patient was sent for surgery.During surgery the laa of the patient was ligated and the effusion was repaired.The patient is doing well following this event and is expected to make a full recovery.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22843599
• Report Number: 2124215-2025-57618
• Device Sequence Number: 9580889
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: (01)00191506013806(17)280130(10)35742763
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: M635TU80010
• Device Catalogue Number: M635TU80010
• Device Lot Number: 0035742763
• 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: 08/06/2025
• Initial Report FDA Received Date: 08/19/2025
• Date Device Manufactured: 01/30/2025
• 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: 79 YR
• Patient Sex: Male