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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 0025375719
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Event Date 02/25/2021
Event Type  Injury  
Event Description

(b)(6) study. It was reported that air embolism with st segment elevation occurred. On (b)(6) 20201 a left atrial appendage (laa) closure procedure was performed. A concomitant ablation using the pulmonary vein isolation ablation and radiofrequency (rf)-point by point technique was also performed. During the watchman procedure, no air was seen, but transient inferior st segment elevations were present after introducing the watchman truseal access sheath. It was speculated, that air was "sucked in" when the truseal and the dilator were in the left atrium across the guidewire and the patient took a deep breath. There is no valve on the dilator and the valve of the truseal was not completely tight because the dilator was in place. A puncture of the right femoral artery was done for coronary angiography with coronary occlusions ruled out. There was spontaneous normalization of the electrocardiogram (ecg). The procedure continued and the patient underwent successful placement of a 24 mm watchman flx closure device with complete laa seal and deployed device diameter of 21 mm. On (b)(6) 2021, the patient was discharged home on aspirin and nonsteroidal anti-inflammatory drugs (nsaids).

 
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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 Key11486825
MDR Text Key240025619
Report Number2134265-2021-03121
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 03/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device LOT Number0025375719
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 Manufactured03/19/2020
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: 03/15/2021 Patient Sequence Number: 1
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