MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/07/2019
Type of Reportable Event	Death
Event or Problem Description
It was reported that a perforation with subsequent tamponade and patient death occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned deep in the laa.A 27mm watchman laa closure device & delivery system (wds) was advanced via the was.Prior to snapping the devices into place, a perforation with subsequent pericardial effusion was noted via fluoroscopy, likely caused by the was.The effusion was confirmed using transesophageal echocardiogram (tee).The procedure continued and the closure device was deployed while a pericardiocentesis kit was being prepared.The patient experienced cardiac tamponade.The release criteria was assessed while the patient's chest was prepped.The criteria was met and the device was released from the core wire.The physician gave anticoagulation reversal and performed a pericardial tap.The physician was unable to slow the bleeding or stabilize the patient.Surgical intervention was requested.The patient was administered blood and the surgeon performed a cut down to the sternum.The bleeding could not be controlled and the patient passed away.

• Brand Name: WATCHMAN ACCESS 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: 8961954
• Report Number: 2134265-2019-10280
• Device Sequence Number: 2563325
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 02/04/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023299788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention