BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    MDR report key: 17543613 · Received August 14, 2023

    Report

    Report Number
    2124215-2023-43189
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    May 24, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE, A WATCHMAN FXD DOUBLE CURVE ACCESS SYSTEM (WAS) WAS POSITIONED, AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE AND DELIVERY SYSTEM WAS USED. THE PHYSICIAN GAINED RIGHT FEMORAL ACCESS AND INSERTED THE WAS WITH A VERSACROSS CONNECT DILATOR AND PIGTAIL WIRE INTO THE SUPERIOR VENA CAVA (SVC). THE IMAGING PHYSICIAN VISUALIZED TENTING IN THE THICK PORTION OF THE SEPTUM, BUT IMPLANTING PHYSICIAN FELT LIKE IT WAS A GOOD PLACE TO CROSS. RADIOFREQUENCY (RF) WAS TURNED ON, BUT THE SYSTEM DID NOT CROSS. THE PHYSICIAN DECIDED TO RE-WIRE THE SVC AND PULL IT DOWN AGAIN. THE NEW LOCATION WAS IN A SIMILAR LOCATION TO THE PRIOR TENT. RF WAS TURNED ON, BUT NO BUBBLES WERE VISUALIZED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND THE WIRE DID NOT CROSS. THE PHYSICIAN PULLED THE SYSTEM MORE INFERIOR AND WAS ABLE TO CROSS. ONCE ACROSS, HE REMOVED THE VERSACROSS DILATOR AND INSERTED A PIGTAIL CATHETER. 15,000 UNITS OF HEPARIN WERE THEN ADMINISTERED TO THE PATIENT. THE IMAGING PHYSICIAN PERFORMED A CHECK AND STATED THAT THERE WAS NOT ANYTHING OUT OF THE NORM. THE 24MM WDS WAS PREPPED, AND THE IMPLANTING PHYSICIAN THEN REMOVED THE PIGTAIL AND INSERTED THE DEVICE. DURING THIS PROCESS, THE PATIENT'S BLOOD PRESSURE STARTED TO FLUCTUATE FROM 60/38 TO 230/135. THE IMAGING PHYSICIAN COMPLETED A SWEEP TO LOOK AT THE ATRIUM AND APPENDAGE. A THROMBUS WAS OBSERVED TO BE FLOATING IN THE ATRIUM. THE IMAGING PHYSICIAN ROTATED THE PROBE TO SEE WHAT THE THROMBUS WAS ATTACHED TO, BUT THE THROMBUS WAS NO LONGER VISIBLE. THE IMPLANTING PHYSICIAN PROCEEDED TO RELEASE THE DEVICE AND THEN CHECKED TO MAKE SURE THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS WOKEN UP AND WAS ADMITTED FOR FREQUENT NEURO CHECKS OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56234 VERSACROSS CONNECT LAAC ACCESS SOLUTION CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention