BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 17545796 · Received August 14, 2023

    Report

    Report Number
    2124215-2023-43251
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    June 13, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DYB
    PMA / PMN Number
    K183655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE DXF THE DEVICE WON'T BE RETURNED FOR ANALYSIS. UPON EVALUATION OF THE FAILURE ANALYSIS OF THE EVENT REPORTED, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    A VERSACROSS ASSESS SOLUTION KIT WAS SELECTED FOR A WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. DURING THE TRANSEPTAL PUNCTURE DROP DOWN, THE SHEATH WASN'T VISUALIZED AS TENTING THE INTER-ATRIAL SEPTUM, SO THE PHYSICIAN WENT BACK UP THE SUPERIOR VENA CAVA AND DROPPED DOWN AGAIN. TENTING STILL WASN'T SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SO THE PHYSICIAN CLOCKED, AND COUNTER CLOCKED THE SHEATH IN ORDER TO FIND THE SHEATH ON TEE. TENTING WAS EVENTUALLY SEEN, AND TRANSEPTAL ACCESS WAS OBTAINED. THE PIGTAIL WIRE WAS ANCHORED IN THE LEFT UPPER PULMONARY VEIN AND A PIGTAIL CATHETER WAS RAILED OVER THE WIRE. THE WIRE WAS REMOVED, AND THE PIGTAIL CATHETER WAS MANEUVERED INTO THE LAA. CONTRAST WAS INJECTED AND THE PIGTAIL CATHETER WAS EXCHANGED FOR THE WDS AND THE DEVICE WAS DEPLOYED. THE POSITION WAS NOT OPTIMAL, SO THE CLOSURE DEVICE WAS RECAPTURED AND RE-DEPLOYED. THE ANESTHESIA TECHNICIAN NOTIFIED THE IMPLANTER THAT THE HEART RATE WAS INCREASING AND THEN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE (A-FIB WITH RVR) WAS SEEN. A CARDIOVERSION WAS PERFORMED, AND TEE SWEPT FOR AN EFFUSION. A LARGE PERICARDIAL EFFUSION WAS SEEN SO THE PATIENT WAS PREPPED FOR PERICARDIOCENTESIS TO TREAT THE EFFUSION. ONCE PERICARDIAL ACCESS WAS SUCCESSFUL, THE DEVICE WAS RELEASED. THE WAS AND WDS WERE REMOVED, AND PROTAMINE WAS GIVEN TO THE PATIENT. 600 CC OF BLOOD WAS DRAINED, AND THE PATIENT WAS MONITORED FOR 30-40 MINUTES TO ENSURE THAT THERE WAS NO RE-ACCUMULATION OF EFFUSION. THE PATIENT WAS STABLE AND SENT TO THE INPATIENT UNIT FOR RECOVERY/OBSERVATION. THE PATIENT DID NOT HAVE ANY RE-ACCUMULATION OF FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300611 VERSACROSS ACCESS SOLUTION INTRODUCER, CATHETER DYB BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H