BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN TRUSEAL ACCESS SYSTEM

    MDR report key: 21105782 · Received January 8, 2025

    Report

    Report Number
    2124215-2024-81171
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CARDIAC PERFORATION, A PERICARDIAL EFFUSION (PE) AND CARDIAC TAMPONADE WERE REPORTED. THE PROCEDURE WAS CANCELLED. IT WAS REPORTED THAT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. AN NTK KIT WAS SELECTED FOR USE. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH NRG RF NEEDLE FROM THE NTK KIT. A WATCHMAN TRUSEAL DOUBLE CURVE ACCESS SYSTEM (WAS) WAS ADVANCED INTO THE LEFT ATRIUM (LA). ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING, IT WAS NOTED THERE WAS POOR VISIBILITY. WHILE THE WAS AND NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE WERE IN THE LA, ATTEMPTS TO SECURE ACCESS IN THE PULMONARY VEIN WERE DIFFICULT, AND A PE WAS VISIBLE IN TEE BEHIND THE LAA. EMERGENCY MANAGEMENT OF THE EVENT WAS INITIATED, AND IT WAS NOTED THERE WAS A CARDIAC PERFORATION IN THE LAA, BLOOD LOSS/HEMORRHAGE, AND CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS CANCELLED. HEART SURGERY WAS PERFORMED IN RESPONSE TO THE LAA CARDIAC PERFORATION. BLOOD TRANSFUSION WAS ADMINISTERED. PATIENT OUTCOME REMAINS UNKNOWN. IN THE PHYSICIAN'S OPINION, THE NON-BSC GUIDEWIRE MAY HAVE CAUSED THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554363 WATCHMAN TRUSEAL ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL DQY BOSTON SCIENTIFIC CORPORATION 0033981158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention