BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 16556259 · Received March 16, 2023

    Report

    Report Number
    2124215-2023-11379
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    February 17, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PRO CODE: DXF, DYB. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VERSACROSS RF WIRE WAS SELECTED FOR USE. AFTER SUCCESSFUL IMPLANTATION OF THE WATCHMAN FLX THE PATIENT WAS SENT TO RECOVER AND THE PATIENT COMPLAINT ABOUT CHEST PAIN, AND A PERICARDIAL EFFUSION WAS CONFIRMED. THE PATIENT WAS THEN TAKEN FOR PERICARDIOCENTESIS. THE ACTIVATED CLOTTING TIME (ACT) WAS 254 DURING THE PROCEDURE AND NO PROTAMINE WAS GIVEN POST IMPLANTATION. ELIQUIS WAS STOPPED 2 DAYS BEFORE. THE FOLLOWING DAY ON FEB 18TH ANOTHER ECHO WAS DONE AND NO ADDITIONAL FLUID WAS NOTED. PATIENT DISCHARGED THE FOLLOWING DAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOR A PROCEDURE A VERSACROSS ACCESS SOLUTION SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER SUCCESSFUL IMPLANTATION OF THE WATCHMAN FLX THE PATIENT WAS SENT TO RECOVER BUT THE PATIENT COMPLAIN ABOUT CHEST PAIN, AND A PERICARDIAL EFFUSION WAS CONFIRMED. THE PATIENT WAS THEN TAKEN FOR PERICARDIOCENTESIS. THE ACTIVATED CLOTTING TIME (ACT) WAS 254 DURING THE PROCEDURE AND NO PROTAMINE WAS GIVEN POST IMPLANTATION. ELIQUIS WAS STOPPED TWO DAYS BEFORE. THE FOLLOWING DAY ON FEB 18TH, ANOTHER ECHO WAS DONE AND NO ADDITIONAL FLUID WAS NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE VERSACROSS DEVICES WERE DISPOSED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456876 VERSACROSS ACCESS SOLUTION CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O VERSACROSS CONNECT TRANSSEPTAL DILATOR| VERSACROSS CONNECT TRANSSEPTAL DILATOR| WATCHMAN FLX| WATCHMAN FLX