MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX? Pro; system, appendage closure, left atrial

Model Number	M635WU60400
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a kink occurred, and the procedure was cancelled.A left atrial appendage (laa) closure procedure was being performed, and a watchman fxd curve access system (was) was selected to be used.The patient was sedated with general anesthesia.During the procedure, transeptal puncture (tsp) was performed in an inferior/posterior location and the physician approached using a was.An attempt was made to deploy the 40mm closure device; however, interference from the posterior pectinate caused the closure device to pop out, resulting in significant protrusion.The was sheath was severely bent and replacing it was unlikely to resolve the issue.Furthermore, due to insufficient space to select an alternative tsp site, the procedure was discontinued at the physician's discretion.It was further reported that there was no report that the watchman access system was kinked and that the report does not indicate that the 40mm closure device and delivery system was bent.It was reported that the sheath was on a severely angulated trajectory, and changing the sheath was not expected to resolve the issue.Therefore, the complaint will be considered non-reportable.
Additional Manufacturer Narrative
B5 describe event or problem: updated with additional information received h6 device code: updated with additional information received.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50358895
• Report Number: 2124215-2026-45006
• Device Sequence Number: 10103227
• Product Code: NGV
• UDI-Device Identifier: 00191506013813
• UDI-Public: (01)00191506013813(17)290109(10)38314593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635WU60400
• Device Catalogue Number: M635WU60400
• Device Lot Number: 0037064246
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026; 09/18/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/09/2026; 09/22/2026
• Date Device Manufactured: 07/27/2025
• 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
• Patient Sex: Unknown