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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pericardial Effusion (3271)
Date of Event 01/14/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.No effusion was noted pre-procedure.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The device was deployed and did not require any partial or full recaptures.Post-implant, a pericardial effusion was noted which required a pericardiocentesis and drain placement.The patient remained stable and was discharged.The drain has been removed.
 
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Brand Name
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
Common Device Name
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11274586
Report Number2134265-2021-00994
Device Sequence Number4279996
Product Code NGV
UDI-Device Identifier08714729838227
UDI-Public08714729838227
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P130013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/16/2022
Device Model Number10371
Device Catalogue Number10371
Device Lot Number0024616461
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/14/2021
Initial Report FDA Received Date02/03/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age85 YR
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