BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 8743410 · Received June 28, 2019

    Report

    Report Number
    2134265-2019-07220
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A PERFORATION WITH CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE TRANSEPTAL PUNCTURE WAS PERFORMED AND 8000 UNITS OF HEPARIN WERE ADMINISTERED. A WATCHMAN ACCESS SYSTEM WAS POSITIONED AND A 33 MM WATCHMAN LAA CLOSURE DEVICE WAS DEPLOYED, BUT IT WAS TOO PROXIMAL. AN IMAGING SWEEP WAS PERFORMED AND SHOWED A PERFORATION RESULTING IN PERICARDIAL EFFUSION WITH TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND 1000 ML OF BLOOD WAS DRAINED. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) WAS THEN 158 SEC. A 30 MM WATCHMAN LAA CLOSURE DEVICE WAS THEN DEPLOYED. THE CLOSURE DEVICE WAS POSITIONED WELL AND THEREFORE RELEASED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN GOOD CONDITION AND HAS SINCE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539027 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10365 0021957866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention