BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 16775753 · Received April 20, 2023

    Report

    Report Number
    2124215-2023-15366
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 21, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    PMA / PMN Number
    K183655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE: DXF, DYB. PREMARKET / 510(K) # K183655,K150709.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL IS FILED FOR CORRECTION IN D2A, D2B AND G4 FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) WITH DIFFICULTY. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS ALSO DIFFICULT. THE GUIDEWIRE HAD TO BE RELOADED THREE TIMES, IN ORDER TO DROP FROM THE SVC. THE PATIENT HAD AN UNUSUAL ANATOMY; THE PATIENT HAD A SMALL SVC AND THE PHYSICIAN WAS HAVING TROUBLE ADVANCING THE WIRE INTO THE SVC. IT WAS NOT POSSIBLE TO ATTEMPT TRANSEPTAL ACCESS AT THIS POINT. AFTER THIS, THE WIRE WAS LOCATED IN THE RIGHT ATRIUM AND A PERICARDIAL EFFUSION WAS DISCOVERED. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. BEFORE THE EFFUSION WAS NOTED JUST THE TABLE WIRE, VERSACROSS PIGTAIL RF WIRE, VERSACROSS SHEATH AND DILATOR WERE THE ONLY PRODUCTS THAT MADE IT INTO THE BODY. THE PATIENT HAS BEEN EXTUBATED AND WAS STABLE THE DAY AFTER THE EVENT. THE DEVICE WILL NOT BE RETURNED SINCE IT WAS DISPOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A WATCHMAN PROCEDURE, A VERSACROSS ACCESS SOLUTION SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) WITH DIFFICULTY. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS ALSO DIFFICULT. THE GUIDEWIRE HAD TO BE RELOADED THREE TIMES, IN ORDER TO DROP FROM THE SVC. AFTER THIS, A PERICARDIAL EFFUSION WAS NOTED, THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. IT IS EXPECTED THAT THE PATIENT WILL FULLY RECOVER. THE DEVICE WILL NOT BE RETURNED SINCE IT WAS DISPOSED. (B)(6) 2023 - GFE RESPONSE: THE PATIENT HAD AN UNUSUAL ANATOMY. ALSO, PATIENT HAD A SMALL SVC. DR. MILLER WAS HAVING TROUBLE ADVANCING THE WIRE INTO THE SVC. ADDITIONALLY ECHO IMAGING WASN'T THE BEST. "WE DIDN'T EVEN GET TO THE POINT OF ATTEMPTING TO GO TRANSSEPTAL." SIZES AND TYPES OF SHEATHS USED: VERSACROSS FIXED KIT. VXSK KIT. 8.5FR. THE WIRE WAS LOCATED IN THE RIGHT ATRIUM AT THE TIME THE PERICARDIAL EFFUSION WAS DISCOVERED. BEFORE THE EFFUSION WAS NOTED JUST THE TABLE WIRE, VERSACROSS PIGTAIL RF WIRE, AND VERSACROSS SHEATH AND DILATOR WERE THE ONLY PRODUCTS THAT MADE IT INTO BODY. PATIENT HAS BEEN EXTUBATED AND WAS STABLE THE DAY AFTER THE EVENT. THAT WAS THE LAST I WAS INFORMED. EXPECTED TO GO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437943 VERSACROSS ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC.
    1591897 VERSACROSS ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention