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 Perforation (2513); Pericardial Effusion (3271)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation and a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 24mm watchman laa closure device & delivery system (wds) were used.The was positioned in the laa and the first 24mm closure device was deployed.The device did not meet release criteria, so a full recapture was performed.This device was removed from the patient and a second closure device was inserted into the was.The physician felt the patient cough at the time the second 24mm device distal marker band was being matched with the was.Before attempting to deploy the second device a slight contrast injection was performed to visualize exactly where the end of the device was located in relation to the back wall of the laa.That injection showed that the contrast was leaving the laa and going into the pericardial space.The physician continued the procedure and deployed the second device in the laa, but it also did not meet release criteria and was fully recaptured.Transesophageal echocardiogram imaging showed that fluid was accumulating in the pericardial space.The physician gave the patient protamine and performed a pericardiocentesis to treat the pericardial effusion.Around 1l of blood was removed from the effusion.A drain was left in the patient overnight to observe if there was any more drainage.There was a little fluid in the drain overnight, but the patient was fine.The drain was removed the next day.The patient was doing fine following these events and they have since been discharged from the hospital.

• 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: 9808302
• Report Number: 2134265-2020-02136
• Device Sequence Number: 643132
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 03/09/2020

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: 03/03/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023433135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention