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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Pericardial Effusion (3271)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed.A 21mm watchman laa closure device was successfully implanted.It was noted there was a small effusion observed prior to the start of the procedure with no change intraprocedural or immediately post procedure.Transthoracic echocardiography (tte) was performed an hour post procedure due to the patient complaint of chest pain, but no change in the effusion was noted at that time.Several hours post procedure, the effusion grew and an open heart pericardial window was performed to treat the effusion.Six days post procedure, the patient was discharged home.
Event or Problem Description
It was reported a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed.A 21mm watchman laa closure device was successfully implanted.It was noted there was a small effusion observed prior to the start of the procedure with no change intraprocedural or immediately post procedure.Transthoracic echocardiography (tte) was performed an hour post procedure due to the patient complaint of chest pain, but no change in the effusion was noted at that time.Several hours post procedure, the effusion grew and an open heart pericardial window was performed to treat the effusion.Six days post procedure, the patient was discharged home.It was further reported that during the pericardial tap, the right ventricle was ruptured.The right ventricle was treated with open heart surgery to close the puncture site.The patient was admitted to the intensive care unit post repair, and discharged to home.

• 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: 12025374
• Report Number: 2134265-2021-07855
• Device Sequence Number: 19176216
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 01/22/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025092298
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention