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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number M635TU70010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Event Date 03/25/2021
Event Type  Injury  
Event 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.

 
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Brand NameWATCHMAN TRUSEAL ACCESS SYSTEM
Type of DeviceSYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11703370
MDR Text Key246594725
Report Number2134265-2021-04473
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM635TU70010
Device Catalogue NumberM635TU70010
Device LOT Number0026544332
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/18/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/21/2021 Patient Sequence Number: 1
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