MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX? PRO; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635WU60400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/12/2026
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 access system (was) and a 40mm watchman flx pro 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 closure device was deployed and recaptured four (4) times, but the closure device did not meet release criteria.The physician exchanged the was for a trusteer was and a new 40mm wds.The physician positioned the new was in the laa of the patient and then inserted the new wds.The closure device was deployed twice and met all release criteria.The closure device was successfully implanted in the laa of the patient.During the check of the laa a trace to mild pericardial effusion was noted.The patient remained hemodynamically stable and no intervention or treatment was required.The physician planned to perform a transthoracic echocardiogram prior to discharge.The patient is expected to make a full recovery from this event and will be discharged from the hospital.
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 access system (was) and a 40mm watchman flx pro 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 closure device was deployed and recaptured four (4) times, but the closure device did not meet release criteria.The physician exchanged the was for a trusteer was and a new 40mm wds.The physician positioned the new was in the laa of the patient and then inserted the new wds.The closure device was deployed twice and met all release criteria.The closure device was successfully implanted in the laa of the patient.During the check of the laa a trace to mild pericardial effusion was noted.The patient remained hemodynamically stable and no intervention or treatment was required.The physician planned to perform a transthoracic echocardiogram prior to discharge.The patient is expected to make a full recovery from this event and will be discharged from the hospital.
Additional Manufacturer Narrative
The device was not returned for analysis as the device remains implanted; therefore, a technical analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: WATCHMAN FLX? PRO
• 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: 24622726
• Report Number: 2124215-2026-14785
• Device Sequence Number: 8698340
• Product Code: NGV
• UDI-Device Identifier: 00191506004637
• UDI-Public: (01)00191506004637(17)270918(10)34877164
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: M635WU60400
• Device Catalogue Number: M635WU60400
• Device Lot Number: 0034877164
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 09/18/2024
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White