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

Model Number	M635WU60240
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device leak occurred.\ \ a left atrial appendage (laa) closure procedure was performed, and a 24mm watchman flx pro closure device was implanted on (b)(6) 2026.During the procedure, there were multiple recaptures and repositions, the patient had a difficult anatomy and was a challenging procedure.The patient was discharged.During a routine follow up computed tomography (ct) scan, a 7mm leak was noted.The ct was sent to the therapy operations team for evaluation.Per the therapy operations report it stated that the distal portion of the appendage showed no signs of contrast nor contrast going around the closure device but that a proximal lobe was left uncovered.After discussion with the physician, there is no plan for intervention.The patient was on eliquis and aspirin medication.

• 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: 50734763
• Report Number: 2124215-2026-48725
• Device Sequence Number: 10591492
• Product Code: NGV
• UDI-Device Identifier: 00191506004590
• UDI-Public: (01)00191506004590(17)290318(10)38871621
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: M635WU60240
• Device Catalogue Number: M635WU60240
• Device Lot Number: 0038871621
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 03/19/2026
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Male