BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23876647 · Received December 23, 2025

    Report

    Report Number
    3012120746-2025-00042
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 18, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00850027837154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE EVENT DATE WAS PRIOR TO THE USE BY DATE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE PREPARATION, THE NDL 900304 FLEXCATH CROSS FC 65CM WAS INADVERTENTLY RENDERED NON-STERILE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS NOTED THAT THE INTEGRATED DILATOR NEEDLE WAS USED PASSED ITS USE BY DATE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381284 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900304 105422 00850027837154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown