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

Model Number	M635WU50240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study.It was reported that perforation and death occurred.A left atrial appendage (laa) closure procedure was performed in a canine as part of a preclinical study.A 24mm watchman flx laa closure device & delivery system (wds) were selected to be used.The closure device was successfully implanted.A gross necropsy observations showed pericardial adhesions present on superior aspect of the laa.An anchor was seen perforating the wall on the laa (adhesions not associated with perforation).No major concerning findings related to cardiac function or overall animal health were reported during the in-life period of the study for this animal.Pathology confirmed an anchor was seen perforating the wall on the laa.
Additional Manufacturer Narrative
B2 outcomes attrib to adv event: updated with additional information received.B5 describe event or problem: updated with additional information received.H1 type of reportable event: updated with additional information received.H6: impact code corrected from f02 death to f26 no health consequences or impact.
Event or Problem Description
Reported via clinical study.It was reported that perforation and death occurred.A left atrial appendage (laa) closure procedure was performed in a canine as part of a preclinical study.A 24mm watchman flx laa closure device & delivery system (wds) were selected to be used.The closure device was successfully implanted.A gross necropsy observations showed pericardial adhesions present on superior aspect of the laa.An anchor was seen perforating the wall on the laa (adhesions not associated with perforation).No major concerning findings related to cardiac function or overall animal health were reported during the in-life period of the study for this animal.Pathology confirmed an anchor was seen perforating the wall on the laa.It was further reported that the animals showed no adverse clinical signs and were euthanized as planned per protocol.

• 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: 23523765
• Report Number: 2124215-2025-78537
• Device Sequence Number: 9770105
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)240506(10)27268917
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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 Expiration Date: 05/06/2024
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0027268917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 05/07/2021
• 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; Death
• Patient Sex: Unknown