BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 16686338 · Received April 5, 2023

    Report

    Report Number
    2124215-2023-15021
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 15, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT BEING FILED TO UPDATE D2A, D2B AND G4 FIELDS. 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

    COMPLAINT CREATED TO CAPTURE THE RF WIRE USED FOR TRANSEPTAL PUNCTURE. IT WAS REPORTED THAT FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE A VERSACROSS RF WIRE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE PLACEMENT OF THE TRANSEPTAL PUNCTURE (TSP) SITE WAS POSTERIOR AND CLOSE TO THE POSTERIOR WALL OF THE LEFT ATRIUM. THE PHYSICIAN PROCEEDED WITH THE WATCHMAN CASE, A WATCHMAN WAS IMPLANTED AND A SMALL EFFUSION WAS NOTED ON ECHOCARDIOGRAPHY. AN UNSUCCESSFUL ATTEMPT WAS MADE TO TAP THE PERICARDIAL EFFUSION. A PERICARDIAL WINDOW WAS PERFORMED AND 350ML OF BLOOD REMOVED. IT WAS INDICATED THAT THE EFFUSION WAS CAUSED BY THE TRANSEPTAL APPROACH. THE PATIENT WENT TO THE INTENSIVE CARE UNIT FOR RECOVERY WITH A PERICARDIAL DRAIN IN PLACE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE A VERSACROSS RF WIRE AND VERSACROSS TRANSSEPTAL DILATOR WERE SELECTED FOR USE. IT WAS OBSERVED THAT THE PLACEMENT OF THE TRANSEPTAL PUNCTURE (TSP) SITE WAS POSTERIOR AND CLOSE TO THE POSTERIOR WALL OF THE LEFT ATRIUM. THE PHYSICIAN PROCEEDED WITH THE WATCHMAN CASE, A WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED, DURING EVALUATION OF RELEASE CRITERIA OF THE CLOSURE DEVICE, A SMALL PERICARDIAL EFFUSION WAS DISCOVERED VIA ECHOCARDIOGRAPHY. AN UNSUCCESSFUL ATTEMPT WAS MADE TO TAP THE PERICARDIAL EFFUSION. A PERICARDIAL WINDOW WAS PERFORMED AND 350ML OF BLOOD REMOVED. IT WAS INDICATED THAT THE EFFUSION WAS CAUSED BY THE TRANSEPTAL APPROACH. THE PATIENT WENT TO THE INTENSIVE CARE UNIT FOR RECOVERY WITH A PERICARDIAL DRAIN IN PLACE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT FULLY RECOVERED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108416 VERSACROSS ACCESS SOLUTION CATHETER, SEPTOSTOMY DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other| R