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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

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BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number 10371
Event Date 01/01/2019
Event Type  Death  
Manufacturer Narrative

Summary reporting exemption approval number - e2017028. This summary report represents 4 patient death events.

 
Event Description

Boston scientific received events as part of the laao/ncdr registry for the watchman left atrial appendage (laa) closure devices, falling under the left atrial appendage occlusion (laao) registry of the american college of cardiology's national cardiovascular data registry (ncdr). Registry. This manufacturer report is being sent as a requirement under summary reporting exemption approval number - e2017028 for product code ngv. The data was downloaded 11 january 2019, due 11 may 2019.

 
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Brand NameWATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
Type of DeviceSYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key8579555
Report Number2134265-2019-04850
Device Sequence Number1
Product CodeNGV
Report Source Manufacturer
Source Type STUDY
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2019
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10371
Device Catalogue Number10371
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/03/2019 Patient Sequence Number: 1
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