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

Model Number	M635WU60310
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pain (1994)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported device embolization occurred.A left atrial appendage closure (laac) procedure was being performed.A watchman access system (was) and a 31mm watchman flx pro laa closure device and delivery system (wds) was selected for use.The wds was advanced, deployed and the closure device was implanted in the laa.As the patient was being moved over to the bed, they complained of arm pain and their blood pressure dropped.It was found that the 31mm closure device had embolized out of the appendage into the mitral valve.A non-boston scientific (bsc) grasping device was used to retrieve the device, and a new 27mm closure device was implanted.There were no further complications, and the patient has been discharged home.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis the watchman flx? pro was not returned; therefore, 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 # m635wu60310 batch # 0039099517.The dhr review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review there was no 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 embolization, pain, and hypotension.Risk review a risk review was completed and confirmed that the events of implant embolization, pain, and hypotension were defined in the risk documentation.These event types have 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 cause not established.

• 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: 50600725
• Report Number: 2124215-2026-46123
• Device Sequence Number: 10634116
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• UDI-Public: (01)00191506004613(17)290415(10)39099517
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: M635WU60310
• Device Catalogue Number: M635WU60310
• Device Lot Number: 0039099517
• 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: 09/29/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/16/2026
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male