BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23423388 · Received October 30, 2025

    Report

    Report Number
    3012120746-2025-00033
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 21, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 12FCC13 PRODUCT TYPE: SHEATH. 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 REPORTED THAT DURING INSERTION OF THE FLEXCATH CROSS INTO THE GROIN FOR A CARDIAC ABLATION PROCEDURE, THE PATIENT MOVED AND IMMEDIATELY EXPERIENCED PAIN IN THE LEG. THE PATIENT DEVELOPED LOW BLOOD PRESSURE, AND CONTRAST INJECTION THROUGH THE FLEXCATH CROSS REVEALED THAT CONTRAST WAS NOT RETAINED IN THE VEIN, INDICATING VASCULAR INJURY. VASCULAR SURGERY EVALUATED THE CASE AND REQUIRED SURGICAL REPAIR OF THE FEMORAL AND EXTERNAL ILIAC VEINS. THE PROCEDURE WAS ABORTED WITH NO ABLATION PERFORMED, AND THE PATIENT¿S HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. THE PATIENT SUSTAINED INJURY AS A RESULT OF THE EVENT AND WAS ALIVE WITH INJURY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542250 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900311 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R SEE H11.