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); Pericardial Effusion (3271)
Date of Event	10/14/2020
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(laa) closure procedure was performed.A watchman access system (was) was positioned.The 6f pigtail catheter was withdrawn from the was and during the advancement of the closure device, the patients body and the was subsequently moved.A contrast injection was performed and an effusion was visualized by fluoroscopy and confirmed by transesophageal echocardiogram (tee).The patient became hypotensive and was given albumin and fluid bolus.Furthermore, protamine was given and the was was removed.The physician performed pericardiocentesis and removed 600mls of blood fluid.The patient remained stable; however, tee confirmed re-accumulation of fluid in the pericardial space.The patient was transferred to the operating room and a decision was made to perform pericardial window surgery.The patient was hemodynamically stable and intubated.The procedure was aborted and the patient remained stable post-surgery and awaits discharge date.

• 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: 10781505
• Report Number: 2134265-2020-15141
• Device Sequence Number: 1126827
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/03/2020

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: 07/23/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0024157445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention