BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS TRANSSEPTAL SHEATH

    MDR report key: 13901601 · Received March 25, 2022

    Report

    Report Number
    9710452-2022-00014
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 24, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    PMA / PMN Number
    K183655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Description of Event or Problem · 0

    A CASE OF PERICARDIAL EFFUSION WAS REPORTED IN A LEFT ATRIAL APPENDAGE (LAA) PROCEDURE WHERE THE VERSACROSS RF WIRE AND VERSACROSS TRANSSEPTAL SHEATH (BAYLIS MEDICAL COMPANY INC.) WERE USED AMONG OTHER DEVICES, INCLUDING THE WATCHMAN FLX DELIVERY SYSTEM (BOSTON SCIENTIFIC CORPORATION). AFTER SUCCESSFUL TRANSSEPTAL PUNCTURE WAS ACHIEVED WITH THE VERSACROSS DEVICES, THE WATCHMAN FLX SHEATH WAS ADVANCED TO THE LAA, WHEN THE PATIENT'S PRESSURE DROPPED, AND AN EFFUSION WAS NOTED AROUND THE RIGHT ATRIUM VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PROCEDURE WAS ABORTED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS LATER TRANSFERRED TO A SURGICAL SUITE, WHERE A SMALL HOLE IN SUPERIOR VENA CAVA WAS IDENTIFIED AND REPAIRED. FOLLOW-UP REQUESTS REVEALED THAT THE PATIENT WAS DISCHARGED AND IS EXPECTED TO FULLY RECOVER. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS BAYLIS MEDICAL DEVICES WERE REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A SEPARATE PROBLEM REPORT HAS BEEN SUBMITTED FOR THE VERSACROSS RF WIRE WITH THE REPORT NUMBER 9710452-2022-00015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054698 VERSACROSS TRANSSEPTAL SHEATH INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L