MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635TU70010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an air embolism.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned in the laa.After the initial contrast injection through the pigtail catheter within the was, the patient experienced st segment elevation.The cardiac anesthesiologist noted via transesophageal echocardiogram (tee) that there was air in the laa and the left ventricle.The physician aspirated back through the was to remove the air and then exchanged the was for a new one.The patient was given epinephrine and they stabilized.There was no issue noted with the first was upon examination outside the patient.The procedure was completed with the second was.Post procedure the patient was assessed and there were no neurological deficits noted.There were no further complications reported.

• Brand Name: WATCHMAN TRUSEAL 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: 11703370
• Report Number: 2134265-2021-04473
• Device Sequence Number: 3534981
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: 12/18/2023
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0026544332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention