BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ACCESS SYSTEM

    MDR report key: 17712269 · Received September 8, 2023

    Report

    Report Number
    2124215-2023-48667
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5 EVENT DESCRIPTION UPDATED. D1 SUSPECT MEDICAL DEVICE CORRECTED FROM WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM TO WATCHMAN ACCESS SYSTEM.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - AWARE DATE OF 05SEPT2023 USED AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC. IT WAS REPORTED VIA SOCIAL MEDIA THAT PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). FOLLOWING THE PROCEDURE A PERSISTENT ATRIAL SEPTAL DEFECT WAS IDENTIFIED. IT WAS PREVIOUSLY REPORTED THE PROCEDURE WAS COMPLETED USING A WDS. IT WAS FURTHER REPORTED THE PROCEDURE WAS ALSO COMPLETED USING A WATCHMAN ACCESS SYSTEM (WAS). IT WAS ALSO FURTHER REPORTED A PERFORATION DID NOT OCCUR BUT THE PATIENT EXPERIENCED TISSUE DAMAGE.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC. IT WAS REPORTED VIA SOCIAL MEDIA THAT PERFORATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). FOLLOWING THE PROCEDURE A PERSISTENT ATRIAL SEPTAL DEFECT WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112802 WATCHMAN ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other