BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23582536 · Received November 18, 2025

    Report

    Report Number
    3012120746-2025-00039
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00763000935504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 900310 FLEXCATH CROSS TRANSSEPTAL SOLUTION WITH LOT 106669 WAS RETURNED AND ANALYZED. THE GUIDEWIRE WAS NOT RECEIVED WITH THE FLEXCATH CROSS. A MINOR DAMAGE/DEFORMATION AT THE DISTAL END OF THE TIP WAS OBSERVED DURING VISUAL INSPECTION. THE USABLE LENGTH, CURVE ANGLE AND PLANARITY VERIFICATION WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. FLEXCATH CROSS AND GUIDEWIRE COMPATIBILITY WAS PERFORMED. A LAB TEST GUIDEWIRE WAS ABLE TO INSERT AND RETRACT THROUGH RETURNED FLEXCATH CROSS WITHOUT ANY RESISTANCE. FLEXCATH CROSS AND SHEATH COMPATIBILITY WAS PERFORMED. A RETURNED FLEXCATH CROSS WAS INSERTED THROUGH THE LAB TEST SHEATH WITHOUT ANY RESISTANCE AND NO DAMAGE WAS OBSERVED ON THE INNER LAYER OF LAB TEST SHEATH. IN CONCLUSION, THE REPORTED SKIVING AND DIFFICULTY ADVANCING GUIDEWIRE WERE NOT OBSERVED DURING TESTING. THE INTEGRATED NEEDLE/DILATOR FAILED THE RETURNED PRODUCT INSPECTION DUE TOA DAMAGED DILATOR 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, AFTER PUNCTURE, THE INNER SHEATH COULD NOT BE WITHDRAWN INTO THE LEFT ATRIUM. WHEN ATTEMPTING TO RETRACT THE GUIDEWIRE, THE GUIDEWIRE BROKE AND THERE WAS A SENSATION OF BLOCKAGE DURING RETRACTION. A SUBSEQUENT ATTEMPT TO REINSERT THE GUIDEWIRE WAS UNSUCCESSFUL DUE TO RESISTANCE, SO THE NEEDLE WAS REMOVED. A SUBSTANCE BELIEVED TO BE A FRAGMENT FROM THE INSIDE OF THE INNER SHEATH WAS FOUND, SO THE PROCEDURE WAS INTERRUPTED. THE PROCEDURE WAS THEN CONTINUED USING AN RF NEEDLE, AND AFTER SWITCHING, IT WAS COMPLETED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237294 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 106669 00763000935504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown