BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN TRUSTEER? ACCESS SYSTEM

    MDR report key: 23593661 · Received November 19, 2025

    Report

    Report Number
    2124215-2025-84000
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    00191506022310
    PMA / PMN Number
    K240018
    Removal / Correction Number
    97423085-FA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: PATIENT CODE E061202 ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN AIR EMBOLISM OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED ON A PATIENT UNDER DEEP SEDATION. A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. THE TRANSEPTAL PUNCTURE (TSP) WAS PERFORMED SUCCESSFULLY. AS THE DILATOR WAS BEING EXCHANGED FOR THE PIGTAIL CATHETER, THE PHYSICIAN REPORTED THAT THE PATIENT ASPIRATED APPROXIMATELY 20CC OF AIR. ST ELEVATION CHANGES WERE NOTICED, ALONG WITH LEFT VENTRICLE (LV) AND RIGHT VENTRICLE (RV) DYSFUNCTION, AND THE PATIENT BLOOD PRESSURE DROPPED. ATROPINE AND EPINEPHRINE WERE ADMINISTERED. A CORONARY ANGIOGRAPHY WAS PERFORMED AND 100% O2 (OXYGEN) WAS ADMINISTERED. NO AIR WAS NOTICED IN THE CORONARIES AT THE TIME AND THE LAAC PROCEDURE WAS COMPLETED. THE ST ELEVATION RESOLVED, AND THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN AIR EMBOLISM OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED ON A PATIENT UNDER DEEP SEDATION. A WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. THE TRANSEPTAL PUNCTURE (TSP) WAS PERFORMED SUCCESSFULLY. AS THE DILATOR WAS BEING EXCHANGED FOR THE PIGTAIL CATHETER, THE PHYSICIAN REPORTED THAT THE PATIENT ASPIRATED APPROXIMATELY 20CC OF AIR. ST ELEVATION CHANGES WERE NOTICED, ALONG WITH LEFT VENTRICLE (LV) AND RIGHT VENTRICLE (RV) DYSFUNCTION, AND THE PATIENT BLOOD PRESSURE DROPPED. ATROPINE AND EPINEPHRINE WERE ADMINISTERED. A CORONARY ANGIOGRAPHY WAS PERFORMED AND 100% O2 (OXYGEN) WAS ADMINISTERED. NO AIR WAS NOTICED IN THE CORONARIES AT THE TIME AND THE LAAC PROCEDURE WAS COMPLETED. THE ST ELEVATION RESOLVED, AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289901 WATCHMAN TRUSTEER? ACCESS SYSTEM CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION M635TU90050 0037345479 00191506022310

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H