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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 M635TU70020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Event Date 03/01/2021
Event Type  Injury  
Event Description

It was reported that an air embolism occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman truseal access system (was) was being used along with a 6f pigtail catheter and a 10f intracardiac echo (ice) catheter. The patient was under conscious sedation and was snoring during the procedure. The sheath valve was open for inserting the pigtail catheter when the patient snored and aspirated air which travelled through the sheath across the transseptal puncture to the left side of the heart. The patient suddenly experienced st segment elevations and an air embolism was discovered soon after in the aorta. The surgery team came in and placed the patient on extracorporeal membrane oxygenation (ecmo). The patient is alert and oriented and responding to commands on both sides.

 
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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 Key11530137
MDR Text Key241080864
Report Number2134265-2021-03507
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 03/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM635TU70020
Device Catalogue NumberM635TU70020
Device LOT Number0026477885
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 Received03/01/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/07/2020
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: 03/19/2021 Patient Sequence Number: 1
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