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

Model Number	M635WU60400
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 40mm watchman flx pro closure device was implanted on (b)(6) 2025.During the procedure at the time of release, the physician noted a small leak.No further intervention was performed at that time and the patient was discharged.The physician planned for closure of the leak, which was successfully performed on (b)(6) 2026 with a non-boston scientific product.There were no patient complications, and the patient is expected to fully recover.
Event or Problem Description
It was reported that a device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 40mm watchman flx pro closure device was implanted on (b)(6) 2025.During the procedure at the time of release, the physician noted a small leak.No further intervention was performed at that time and the patient was discharged.The physician planned for closure of the leak, which was successfully performed on (b)(6) 2026 with a non-boston scientific product.There were no patient complications, and the patient is expected to fully recover.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis the watchman flx? pro remains implanted; 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 flx? pro, part # m635wu60400, batch # 0036958460.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 evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman flx? pro 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 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.

• 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: 24261611
• Report Number: 2124215-2026-06473
• Device Sequence Number: 9513684
• Product Code: NGV
• UDI-Device Identifier: 00191506004637
• UDI-Public: (01)00191506004637(17)280713(10)36958460
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/25/2026

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 Model Number: M635WU60400
• Device Catalogue Number: M635WU60400
• Device Lot Number: 0036958460
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 07/14/2025
• 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
• Patient Age: 80 YR
• Patient Sex: Male