BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

    MDR report key: 24069949 · Received January 14, 2026

    Report

    Report Number
    2124215-2026-02475
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 26, 2025
    Report Date
    February 18, 2026
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO ADDITIONAL INFORMATION RECEIVED, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR THE UPDATED FIELD DESCRIBE EVENT OR PROBLEM (B5), IN SECTION B - ADVERSE EVENT OR PRODUCT PROBLEM. 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. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS NOT AVAILABLE. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

    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. GOOD FAITH EFFORT ATTEMPTS TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT ARE IN PROGRESS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. GOOD FAITH EFFORTS TO OBTAIN THE INFORMATION ARE IN PROGRESS. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING AN ATRIAL FIBRILLATION ABLATION WITH FARAPULSE PROCEDURE, A FARAWAVE NAV CATHETER AND VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WERE SELECTED FOR USE. THERE WAS A SMALL TO MODERATE BASELINE EFFUSION NOTED AT THE START OF THE PROCEDURE. THE PHYSICIAN COMPLETED THE PULMONARY VEIN ISOLATION PROCEDURE AND DURING POST MAP, A PRESSURE DROP WAS NOTED. THE EFFUSION WAS CHECKED AND AN INCREASE WAS NOTED. PATIENT'S CHEST WAS THEN TAPPED AND DRAINED 360ML. PATIENT REMAINED STABLE THE ENTIRE TIME AND WAS EXTUBATED AND WOKE UP WITHOUT ISSUES. THE PATIENT WAS ADMITTED FOR OBSERVATION BUT AWAKE AND DOING WELL PER OPERATING PHYSICIAN. IN THE PHYSICIAN OPINION, THE A NON-BOSTON SCIENTIFIC GUIDEWIRE MAY HAVE PERFORATED AN UNKNOWN AREA OF THE LEFT ATRIUM. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). IT WAS FURTHER REPORTED THAT NO DIFFICULT DURING TRANSSEPTAL WAS NOTED. THE PE WAS LOCATED AROUND RIGHT VENTRICLE (RV), AND A MODERATE BASELINE EFFUSION WAS NOTED IN THIS LOCATION. ACT WAS THERAPEUTIC. THE PATIENT HAS BEEN DISCHARGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION (PE) OCCURRED. DURING AN ATRIAL FIBRILLATION ABLATION WITH FARAPULSE PROCEDURE, A FARAWAVE NAV CATHETER AND VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WERE SELECTED FOR USE. THERE WAS A SMALL TO MODERATE BASELINE EFFUSION NOTED AT THE START OF THE PROCEDURE. THE PHYSICIAN COMPLETED THE PULMONARY VEIN ISOLATION PROCEDURE AND DURING POST MAP, A PRESSURE DROP WAS NOTED. THE EFFUSION WAS CHECKED AND AN INCREASE WAS NOTED. PATIENT'S CHEST WAS THEN TAPPED AND DRAINED 360ML. PATIENT REMAINED STABLE THE ENTIRE TIME AND WAS EXTUBATED AND WOKE UP WITHOUT ISSUES. THE PATIENT WAS ADMITTED FOR OBSERVATION BUT AWAKE AND DOING WELL PER OPERATING PHYSICIAN. IN THE PHYSICIAN OPINION, THE A NON-BOSTON SCIENTIFIC GUIDEWIRE MAY HAVE PERFORATED AN UNKNOWN AREA OF THE LEFT ATRIUM. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127231 VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R