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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 Problem Air Embolism (1697)
Event Date 06/22/2021
Event Type  Injury  
Event Description

It was reported an air embolism occurred. A left atrial appendage (laa) closure procedure was being performed. A double curve truseal watchman access system (was) was positioned and a 31mm watchman flx laa closure device & delivery system (wds) were used. During the case after the left atrial (la) pressure was measured, the physician decided to give the patient a few cc's of heparinized saline into the side arm of the was sheath from a manifold. Approximately 30 cc's of fluid was given, the blue valve was closed and blood was pulled back prior to pushing anything forward to check for air. There was no imaging being done during this time. The device was prepped as normal and checked for air. A wet to wet connection was performed and the device was successfully deployed. It was after this that air was noted in the laa and left ventricle and the patient's hemodynamics began to suffer. Both the patient's blood pressure and heart rate dropped. The patient was given pressor, and placed on maximum oxygenation. The air was monitored in the heart for a while and aspiration of bubbles was attempted but eventually went on to pass through the circulatory system. The device was not in good position after the first deployment so the physician placed the flx device back in flx ball form. While the air situation was resolving itself and the patient's hemodynamics stabilized, the physician decided to continue the procedure. The device was successful deployed after second deployment and release criteria was met. Air remained behind the device in the distal potion of the appendage. The patient was admitted under normal attention and neurological status was monitored. The following morning, the patient was reported to be doing fine and was discharged home that same day. It is believed that the air entered during a flush of the was sheath prior to entry of the wds.

 
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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 Key12144432
MDR Text Key260827526
Report Number2134265-2021-08576
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 07/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2021
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 Number0027014658
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 Received06/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/22/2021
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: 07/09/2021 Patient Sequence Number: 1
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