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

Model Number	M635TU20060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Quarterly reporting period: q2 2025.Average time to event: 0 days.Device evaluation: under the terms and conditions of the registry, anonymized data was provided.No products were returned as part of the registry.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the "potential adverse events" list in the fda-approved instructions for use (ifu).Registry name: watchman flx pro device surveillance post approval analysis (watchman flx pro surpass).
Event or Problem Description
This report summarizes 2 serious injury events for vessel pseudoaneurysm.Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines.Device relationship to the events reported is not provided.Type of procedure: left atrial appendage closure.Boston scientific received notification of events for the watchman laac device reported in the left atrial appendage occlusion registry (laao) registry, watchman flx pro surpass clinical study to assess long-term safety and effectiveness outcomes associated with the use and implantation of the watchman flx pro left atrial appendage (laa) closure device with delivery system in a routine clinical setting.Patient events were reported as event terms with no further detailed information.Multiple event terms may apply to a single patient but are captured separately under the terms of the summary reporting guidelines.Data includes newly implanted patients and follow up of patients included in the previous data set.Under the terms and conditions of the registry, data is anonymized before being transmitted to bsc, thus there are significant limitations to bsc's ability to correlate the data to information previously reported as a spontaneous complaint.The registry does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
Event or Problem Description
This report summarizes 1 serious injury event for vessel pseudoaneurysm.Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines.Device relationship to the events reported is not provided.Type of procedure: left atrial appendage closure.Boston scientific received notification of events for the watchman laac device reported in the left atrial appendage occlusion registry (laao) registry, watchman flx pro surpass clinical study to assess long-term safety and effectiveness outcomes associated with the use and implantation of the watchman flx pro left atrial appendage (laa) closure device with delivery system in a routine clinical setting.Patient events were reported as event terms with no further detailed information.Multiple event terms may apply to a single patient, but are captured separately under the terms of the summary reporting guidelines.Data includes newly implanted patients and follow up of patients included in the previous data set.Under the terms and conditions of the registry, data is anonymized before being transmitted to bsc, thus there are significant limitations to bsc's ability to correlate the data to information previously reported as a spontaneous complaint.The registry does not provide a causality relationship for each reported event to the device.No further information is available to bsc.
Additional Manufacturer Narrative
Corrected information: age at time of event, unit of measure - age (a2), describe event or problem (b5), no.Of events summarized (h1), fda exemption number, additional mfr narrative (h11).This report was previously filed under exemption e2017028.Quarterly reporting period: q2 2025 average time to event: 0 days device evaluation: under the terms and conditions of the registry, anonymized data was provided.No products were returned as part of the registry.It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint.However, the events reported were anticipated in nature as defined by the "potential adverse events" list in the fda-approved instructions for use (ifu).Registry name: watchman flx pro device surveillance post approval analysis (watchman flx pro surpass).

• Brand Name: WATCHMAN ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA
• 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: 22865943
• Report Number: 2124215-2025-49685
• Device Sequence Number: 9175488
• Product Code: NGV
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Exemption Number: RWD2001468
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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
• Device Model Number: M635TU20060
• Device Catalogue Number: M635TU20060
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Unknown