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

Model Number	M635WU50200
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 20mm watchman flx closure device was successfully implanted on (b)(6) 2023.The patient was discharged.Roughly 3 years post implant on (b)(6) 2026, during an electrophysiology procedure, it was noted on transesophageal echocardiography (tee) that the patient had a 6mm leak around the closure device.The patient has not experienced any adverse events related to this leak and was on plavix and aspirin.The leak was noted in the 135-180-degree range on tee.Lower angles look well opposed.There were no patient complications.No further information was provided at the time of this report.
Event or Problem Description
It was reported that a device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 20mm watchman flx closure device was successfully implanted on (b)(6) 2023.The patient was discharged.Roughly 3 years post implant on (b)(6) 2026, during an electrophysiology procedure, it was noted on transesophageal echocardiography (tee) that the patient had a 6mm leak around the closure device.The patient has not experienced any adverse events related to this leak and was on plavix and aspirin.The leak was noted in the 135-180-degree range on tee.Lower angles look well opposed.There were no patient complications.No further information was provided at the time of this report.It was further reported that the patient has a variety of other medical concerns, vascular is the main one known of with an abdominal aortic aneurysm (aaa) repair a few years back.The patient will remain on anticoagulation medication.
Additional Manufacturer Narrative
B5 describe event or problem: updated with additional information received.H6: impact code added.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis the watchman flx? remains implanted; therefore, returned device analysis could not be completed.Media review: the provided medical media was captured during a follow up appointment and does not require further review by the bsc medical safety team.Device history record review: a review was completed of the device history records (dhr) for the watchman flx?, part # m635wu50200, batch # 0031400498.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman flx? instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include implant did not seal (medication required).Risk review: a risk review was completed and confirmed that the event of implant did not seal was defined in the risk documentation.This event type has 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 known inherent risk of device.
Event or Problem Description
It was reported that a device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 20mm watchman flx closure device was successfully implanted on (b)(6) 2023.The patient was discharged.Roughly 3 years post implant on (b)(6) 2026, during an electrophysiology procedure, it was noted on transesophageal echocardiography (tee) that the patient had a 6mm leak around the closure device.The patient has not experienced any adverse events related to this leak and was on plavix and aspirin.The leak was noted in the 135-180-degree range on tee.Lower angles look well opposed.There were no patient complications.No further information was provided at the time of this report.It was further reported that the patient has a variety of other medical concerns, vascular is the main one known of with an abdominal aortic aneurysm (aaa) repair a few years back.The patient will remain on anticoagulation medication.

• Brand Name: WATCHMAN FLX?
• 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: 24115732
• Report Number: 2124215-2026-03514
• Device Sequence Number: 5941611
• Product Code: NGV
• UDI-Device Identifier: 08714729860488
• UDI-Public: (01)08714729860488(17)260410(10)31400498
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2026
• Device Model Number: M635WU50200
• Device Catalogue Number: M635WU50200
• Device Lot Number: 0031400498
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 01/20/2026; 03/23/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/21/2026; 03/24/2026
• Date Device Manufactured: 04/11/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Race: White