BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23470047 · Received November 4, 2025

    Report

    Report Number
    3012120746-2025-00035
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 26, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00850027837970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 900310 INTEGRATED DILATOR/NEEDLE WAS RETURNED AND ANALYZED. THE INTEGRATED DILATOR/NEEDLE WAS NOT RECEIVED WITH GUIDEWIRE. DAMAGE AT THE DISTAL TIP WAS OBSERVED AT THE DISTAL END. THE USABLE LENGTH, CURVE ANGLE AND PLANARITY VERIFICATION WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. A LAB TEST GUIDEWIRE COULD NOT BE INSERTED THROUGH RETURNED INTEGRATED DILATOR/NEEDLE DUE TO A DAMAGED AT THE DISTAL TIP. 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 REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE INVOLVING THE NDL 900310 FLEXCATH CROSS FCC 10FR, THERE WAS DIFFICULTY PASSING THE INTEGRATED DILATOR/NEEDLE OVER THE GUIDEWIRE, AND A DEFORMITY WAS NOTED ON THE TIP OF THE INTEGRATED DILATOR/NEEDLE AFTER THE SHEATH AND NEEDLE WERE REMOVED. THE PATIENT EXPERIENCED SUSPECTED VENOUS DISSECTION, LOW BLOOD PRESSURE, AND VASCULAR INJURY. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA BEFORE TRANSSEPTAL DEVICE USAGE, AND NO ABLATION WAS PERFORMED. THE PATIENT RECEIVED A UNIT OF BLOOD AND FLUIDS, AND A BALLOON INTERVENTION WAS PERFORMED TO THE VEIN. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226562 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 107026 00850027837970

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H