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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 M635TU70040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Air Embolism (1697)
Event Date 09/09/2020
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 access system (was) was positioned and a watchman laa closure device & delivery system (wds) were selected to be used. While trying to position the was in the laa of the patient a contrast injection was performed to view where the sheath was located. It was then noted on transesophageal echocardiogram and fluoroscopy that there was an air embolism present in the left upper pulmonary vein (lupv). The pigtail catheter was removed from the patient and the was positioned at the lupv entrance. The was slowly advanced while aspirating. The air was aspirated back into the was and could no longer be seen on any of the imaging modalities. There were no st elevations nor any other complications from the air embolism. The procedure was then continued after this, but ultimately a closure device was not implanted in the patient due to the patients anatomy. The patient was doing well following the procedure and there were no other reported complications as a result of this event.

 
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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 Key10609897
MDR Text Key209338800
Report Number2134265-2020-13031
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 09/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM635TU70040
Device Catalogue NumberM635TU70040
Device LOT Number0025345013
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 Received09/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/11/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/30/2020 Patient Sequence Number: 1
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