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

Model Number	M635WU60240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pulmonary Edema (2020)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via patient call center, it was reported fluid accumulation in the lungs occurred post procedure.A left atrial appendage (laa) closure procedure was performed, and a 24mmmm watchman flx pro closure device was implanted on (b)(6) 2026.The patient was subsequently discharged.The patient's daughter contacted the watchman call center to report that her father has experienced ongoing fluid accumulation in his lungs since undergoing the watchman procedure.According to the patient's daughter, the patient began experiencing shortness of breath approximately 3 to 4 days after the procedure.He returned to his physician and was prescribed cortisone; however, the medication did not appear to improve his symptoms.Approximately three weeks later, the patient was taken to the hospital, where he was found to have fluid in his lungs.The patient was subsequently started on lasix.However, each time attempts have been made to taper or discontinue the medication, fluid reaccumulates.The patient's daughter believes the symptoms are directly related to the watchman procedure, as the patient had never experienced this issue previously.She further reported that the patient has been evaluated by three cardiologists, the implanting physician and his primary care physician.According to the daughter, none of the physicians have been able to identify a cause for the fluid accumulation.Their current recommendation has been for the patient to continue taking lasix.The patient's daughter stated that the watchman procedure itself was reported to have gone well.The patient also underwent the routine follow-up transesophageal echocardiography (tee).Following review of the tee, the implanting physician recommended that the patient remain on pradaxa until his next scheduled appointment on (b)(6) 2026.

• 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: 50379357
• Report Number: 2124215-2026-45204
• Device Sequence Number: 18635615
• Product Code: NGV
• UDI-Device Identifier: 00191506004590
• UDI-Public: (01)00191506004590(17)280806(10)37148715
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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 Model Number: M635WU60240
• Device Catalogue Number: M635WU60240
• Device Lot Number: 0037148715
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 08/07/2025
• 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: Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Male