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	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was being inserted into the patient and the physician felt the trajectory for positioning in the laa was not ideal.The physician had to turn the sheath counterclockwise more than usual.The was took a 360 turn and it went through the wall of the appendage.The procedure was immediately stopped.The patient had a pericardial effusion that had developed from this and their blood pressure started to decrease.The patient was tapped on the table and the physician removed 1200cc of fluid.The effusion did not resolve and their was a hole in the appendage so the surgeon was called in.The cardiac surgeon performed a pericardial window and clipped off the appendage of the patient.The patient recovered and is stable following these events and they were brought to the intensive care unit for further monitoring.The patient is currently doing well following these events.

• 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: 9203409
• Report Number: 2134265-2019-12306
• Device Sequence Number: 3107236
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/17/2019

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: 05/06/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023751421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention