MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - aware date used as event date is unknown.
Event or Problem Description
It was reported that a leak occurred.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device was implanted.At implant there was no leak and at the patient's 45-day follow-up, there was a 3-4mm leak shown.The patient had been doing well and when she went into atrial fibrillation, the physician wanted to cardiovert, so a transesophageal echo (tee) was obtained and a large 9mm leak was noted.A computed tomography (ct) scan was performed and showed a 7mm leak.The physician is planning to close the leak in the next couple of months.The patient is doing well and has had no issues as a result of this event.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11827082
• Report Number: 2134265-2021-06332
• Device Sequence Number: 11766108
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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 Expiration Date: 08/28/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0022582726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other