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	09/09/2020
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.The transseptal puncture was performed and it was noted that the septum was very thick throughout.A watchman single curve access system (was) was inserted to the left side of the heart and pigtail catheter was inserted.There was an attempt to find the appendage unsuccessfully and the physician switched to a double curve was.After the exchange, the sheath and the pigtail were advanced into the appendage and an angiography was taken.Immediately after the angiography, the patients pressure noticeably dropped.A transesophageal echocardiography (tee) of the heart was performed and a small effusion was noted in the pericardium.The physician removed the sheath and catheter out of the body and the effusion increased to 1cm.A pericardiocentesis was performed and after 45 minutes, the patient was transferred to have surgery.The surgeon noted a small tear in the right atrium to inferior vena cava (ivc) junction and the right ventricle.The physician believed the tears were not from the was.The procedure was aborted and the patient remained stable and has since been discharged.

• 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: 10602977
• Report Number: 2134265-2020-13373
• Device Sequence Number: 3158698
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/29/2020

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: 02/25/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025269984
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention