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

Model Number	M635WU60270
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device embolization occurred.The patient required surgical removal.A left atrial appendage (laa) closure procedure was being performed under transesophageal echocardiography (tee) guidance.Pre-procedure imaging demonstrated challenging laa anatomy.Transseptal puncture was performed using a fixed versacross transseptal system.A 27mm watchman flx pro delivery system and closure device (wds) was initially attempted but was displaced proximally due to the appendage anatomy.A 24mm wds was then attempted but did not achieve adequate compression.The physician subsequently returned to a 27mm wds using a watchman trusteer access system (was).After several positioning attempts, the 27mm wds met release criteria and was released.Following release, the closure device appeared to have shifted.The physician elected to retrieve the closure device and abort the procedure.After recrossing the septum and advancing a biotome for retrieval, the sheath contacted the closure device, causing it to dislodge and embolize into the left ventricular outflow tract (lvot).Percutaneous retrieval from the lvot was attempted but was unsuccessful.Cardiovascular surgery was consulted, and the patient was taken to the operating room, where the closure device was surgically removed and the laa was clipped.The patient was transferred to recovery and is expected to fully recover.It was further reported the patient was kept in the hospital for several days following the surgery then discharged to a rehab facility to help with recovery.
Additional Manufacturer Narrative
B2: outcome added: hospitalization - initial or prolonged.B5: information added.H6 impact codes added: hospitalization or prolonged hospitalization and rehabilitation.

• 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: 50723732
• Report Number: 2124215-2026-48577
• Device Sequence Number: 15992427
• Product Code: NGV
• UDI-Device Identifier: 00191506004606
• UDI-Public: (01)00191506004606(17)290412(10)39074835
• 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): 09/17/2026

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: M635WU60270
• Device Catalogue Number: M635WU60270
• Device Lot Number: 0039074835
• 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: 09/03/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/13/2026
• 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: 88 YR
• Patient Sex: Female