BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

    MDR report key: 24674486 · Received March 24, 2026

    Report

    Report Number
    2124215-2026-16040
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXF
    UDI-DI
    00685447020158
    PMA / PMN Number
    K150709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): DXF REPORTED HERE AS THE PRO CODE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FARAPULSE PROCEDURE, A VERSACROSS CONNECT FOR FARADRIVE ACCESS SOLUTIONS KIT WAS SELECTED FOR USE. DURING INSERTION OF THE RF WIRE INTO THE BODY OF THE PATIENT, THE COATING ON THE PROXIMAL PART OF THE RF WIRE PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238274 VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE CATHETER, SEPTOSTOMY DXF BOSTON SCIENTIFIC CORPORATION VXAK2041 0037503067 00685447020158

    Patients

    Seq Age Sex Outcome Treatment
    1