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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number 10373
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Air Embolism (1697)
Date of Event 06/29/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.The was was positioned in the laa of the patient when the physician noted that there was air in the appendage.The procedure was completed and the patient received a 27mm closure device.There were no interventions performed.The patient had no hemodynamic changes and had no residual effects as a result of this event.The patient was discharged doing fine the following day.
 
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Brand Name
WATCHMAN ACCESS SYSTEM
Common Device Name
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10303419
Report Number2134265-2020-09546
Device Sequence Number485283
Product Code NGV
UDI-Device Identifier08714729838197
UDI-Public08714729838197
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
P130013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/21/2020
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 Date11/25/2022
Device Model Number10373
Device Catalogue Number10373
Device Lot Number0024832672
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/02/2020
Initial Report FDA Received Date07/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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