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 Code	Pericardial Effusion (3271)
Date of Event	03/20/2020
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 positioned and a 33mm watchman laa closure device & delivery system (wds) were used.The physician performed the transseptal puncture and the was inserted into the patient.After the was placed through the septum, it was noted that the patient had a pericardial effusion.The pressures were slightly decreased but treated.There was no intervention that was required for the patient.The procedure was continued and a 33mm device was implanted successfully in the laa of the patient.There were no other complications that were reported.The patient was doing fine post procedure 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: 9960197
• Report Number: 2134265-2020-04175
• Device Sequence Number: 2596128
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/14/2020

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: 09/16/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0024445508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention