BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 9897511 · Received March 30, 2020

    Report

    Report Number
    2134265-2020-03877
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    January 9, 2020
    Report Date
    March 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729838234
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. THE INITIAL ACT DURING THE PROCEDURE WAS 185 SEC SO AN ADDITIONAL BOLUS OF HEPARIN WAS GIVEN AND THEN UPON RECHECK IT WAS >400 SEC. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO ISSUES. FIVE HOURS POST-PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS CONFIRMED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS DISCHARGED A FEW DAYS LATER ON ASPIRIN ONLY AND HAD HER 45-DAY FOLLOW-UP TEE WHICH LOOKED GOOD ACCORDING TO THE PHYSICIAN. NO CLOT WAS NOTED AND THE 2MM LEAK REMAINED WHICH WAS UNCHANGED FROM THE DAY OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360871 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0024495622 08714729838234

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention