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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 Codes Hematoma (1884); Low Blood Pressure/ Hypotension (1914)
Date of Event 10/21/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that there was a hematoma.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.The procedure was completed and the closure device was successfully implanted in the laa of the patient.After the procedure was completed the patient had a drop in their blood pressure and a large hematoma was noted in the right groin area.The patient was stable following these events and was sent to the intensive care unit for observation.No intervention was required for the events and the patient recovered and is doing well.The patient has since been discharged from the hospital.
 
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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 Key9324194
Report Number2134265-2019-13503
Device Sequence Number14100434
Product Code NGV
UDI-Device Identifier08714729838210
UDI-Public08714729838210
Combination Product (Y/N)N
Initial Reporter StateAZ
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) 11/14/2019
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 Model Number10373
Device Catalogue Number10373
Device Lot Number0024164087
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/21/2019
Initial Report FDA Received Date11/14/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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