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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
Lot Number 0024886085
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Air Embolism (1697)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that there was an air embolism. A left atrial appendage (laa) closure procedure was being performed. The trans-septal puncture was performed successfully in a posterior inferior position. The left upper pulmonary vein was accessed successfully and a watchman truseal access system (was) was prepared and exchanged. The physician connected the fluid to the side port of the was. Before inserting the pigtail catheter, the patient took a deep breath. Air embolism was noted inside the left ventricle of the patient. The patient experienced st segment elevation as a result. The air was successfully removed from the left ventricle using a pigtail catheter and the patient was cleared of any other air being present. The procedure was paused for 5 minutes to observe the patient and with normal electrocardiogram (ecg) seen the procedure was continued. The physician successfully completed the procedure and the 24mm watchman flx laa closure device was implanted in the laa of the patient. There were no other complications that occurred and the patient is doing fine following these events.

 
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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 Key10701293
MDR Text Key212061378
Report Number2134265-2020-13782
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device LOT Number0024886085
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 Received09/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2019
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: 10/19/2020 Patient Sequence Number: 1
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