BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS STEERABLE ACCESS SOLUTION

    MDR report key: 16655439 · Received March 31, 2023

    Report

    Report Number
    2124215-2023-11731
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 8, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    UDI-DI
    00685447012078
    PMA / PMN Number
    K190688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VERSACROSS STEERABLE ACCESS SOLUTION SHEATH WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE SHEATH UNDERWENT A VISUAL INSPECTION, VHX TESTING, AND LEAKAGE TESTING. PRIOR TO DECONTAMINATION, THE SHEATH AND DILATOR WERE VISUALLY INSPECTED, AND BLOOD WAS OBSERVED IN THE SIDEPORT TUBING. THE SHEATH VALVE WAS INSPECTED UNDER MAGNIFICATION, WHICH REVEALED DRIED BLOOD OUTSIDE THE VALVE AND VALVE DAMAGE. THE HEMOSTASIS VALVE AIR AND LIQUID LEAKAGE TESTS WERE THEN PERFORMED, AND IN ALL TESTS, THE REQUIRED PRESSURE COULD NOT BE MET DUE TO EITHER WATER LEAKING THROUGH THE VALVE OR AIR BUBBLES ENTERING THROUGH THE VALVE. THE REPORTED CLINICAL OBSERVATIONS OF LEAKING AND VALVE DAMAGE WERE CONFIRMED BY ANALYSIS, THOUGH THE SHEATH/DILATOR INTERACTION ALLEGATION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    PRO CODE (PRODUCT CODE): D2B, DXF AND DYB. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHEATH EXHIBITED A SHEATH LEAK AND A TEAR IN THE HEMOSTATIC VALVE. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) A VERSACROSS STEERABLE ACCESS SOLUTION SHEATH WAS SELECTED FOR USE. THE SHEATH EXHIBITED A HEMOSTATIC VALVE LEAK. THE LEAK WAS A SLOW DRIP OF SALINE WITH NOT A LOT OF BLOOD PRESENT. BACKLOADING THE DILATOR INTO THE SHEATH MAY HAVE TORN THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED WITH ANOTHER OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHEATH EXHIBITED A SHEATH LEAK AND A TEAR IN THE HEMOSTATIC VALVE. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) A VERSACROSS STEERABLE ACCESS SOLUTION SHEATH WAS SELECTED FOR USE. THE SHEATH EXHIBITED A HEMOSTATIC VALVE LEAK. THE LEAK WAS A SLOW DRIP OF SALINE WITH NOT A LOT OF BLOOD PRESENT. BACKLOADING THE DILATOR INTO THE SHEATH MAY HAVE TORN THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED WITH ANOTHER OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059659 VERSACROSS STEERABLE ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC. VSTK0016 VKFG170622 00685447012078
    598594 VERSACROSS STEERABLE ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC. VSTK0016 VKFG170622 00685447012078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown