BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS TRANSSEPTAL SHEATH

    MDR report key: 14249847 · Received April 29, 2022

    Report

    Report Number
    9710452-2022-00024
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    UDI-DI
    00685447003595
    PMA / PMN Number
    K183655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. A DHR REVIEW ON ALL DEVICES IN THE LOT WAS COMPLETED AND ALL DEVICES MET RELEVANT SPECIFICATIONS PRIOR TO RELEASE; DEVICE MALFUNCTION IS NOT SUSPECTED.

    Description of Event or Problem · 0

    DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE, THE VERSACROSS TRANSSEPTAL SHEATH AND VERSACROSS RF WIRE (BAYLIS MEDICAL COMPANY INC.) WERE USED FOR THE INITIAL TRANSSEPTAL PUNCTURE OF THE PROCEDURE WITH NO OBSERVED INITIAL COMPLICATIONS. AFTER TRANSSEPTAL PUNCTURE, THE WATCHMAN FLX (BOSTON SCIENTIFIC CORP.) DEVICES WERE USED TO COMPLETE THE LAAC PROCEDURE. UPON POST-PROCEDURE VERIFICATION, THE PATIENT WAS NOTED TO HAVE A HEMOTHORAX. THE HEMOTHORAX WAS DRAINED AND THE PATIENT WAS KEPT FOR OBSERVATION. FOLLOW-UP REQUESTS REVELED THAT THE PATIENT IS DOING WELL AND IS EXPECTED TO RECOVER. AS THE HEMOTHROAX WAS IDENTIFIED AFTER COMPLETION OF THE CLOSURE PROCEDURE, THERE IS NO OBJECTIVE EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS DEVICES WERE 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 REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114550 VERSACROSS TRANSSEPTAL SHEATH INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC. VXS85-35-63-55-D1 VXFC220621 00685447003595

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention