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	Cardiac Arrest (1762); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion, perforation, and cardiac arrest occurred.A left atrial appendage (laa) closure procedure was performed.A watchman access system (was) was positioned.Prior to removing the pigtail to implant the device, the anesthesiologists pointed out a 2.5cm pericardial effusion that was not present at the start of the procedure.The patient was immediately administered 50mg of protamine and a pericardial drain was placed with 2200cc of fluids removed.Additionally, the patient was given 4 units of blood and was placed on epinephrine drip.The patient was transferred to the surgical suite where the surgeon noted a small tear in the lower pulmonary vein.The surgeon proceeded to stitch the tear and clipped the appendage.The patient experienced bradycardia post surgery but remained stable.The next day the patient coded and received a permanent pacemaker.The patient remained hospitalized due to a wound on their shoulder, of unknown origin.The patient became septic from the wound and died four days post procedure.

• 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: 10437003
• Report Number: 2134265-2020-10370
• Device Sequence Number: 16842889
• 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): 08/20/2020

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: 01/09/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025017494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR