BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23213535 · Received October 3, 2025

    Report

    Report Number
    3012120746-2025-00030
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    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 INTEGRATED DILATOR/NEEDLE WITH LOT NUMBER 106379 WAS RETURNED AND ANALYZED. NO ANOMALIES WERE OBSERVED DURING VISUAL INSPECTION OF THE INTEGRATED DILATOR/NEEDLE. THE USABLE LENGTH, CURVE ANGLE, AND PLANARITY VERIFICATION WAS PERFORMED AND NO ANOMALIES WERE OBSERVED. THE INTEGRATED DILATOR/NEEDLE WAS INSERTED THROUGH A TEST SHEATH AND THE RETURNED SHEATH WITHOUT ANY RESISTANCE. IN CONCLUSION, THE REPORTED AIR INGRESS WAS NOT CONFIRMED/REPRODUCED DURING TESTING. THE INTEGRATED DILATOR/NEEDLE PASSED THE RETURNED PRODUCT INSPECTION PER SPECIFICATION. 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

    CONTINUATION OF D10: PRODUCT ID PSG100 (SERIAL: UNKNOWN); PRODUCT TYPE: 3294-GENERATOR PRODUCT ID 900310 (106647); PRODUCT TYPE: 3288-ACQ NEEDLE PRODUCT ID 10FCC13 (0012897272); PRODUCT TYPE: 0629-FLEXCATH SHEATH PRODUCT ID: NON-MEDTRONIC PRODUCT PRODUCT TYPE: TRANSSEPTAL NEEDLE 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 WHEN THE INTEGRATED DILATOR/NEEDLE WAS REPLACED THE AIR INGRESS CONTINUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, WHEN THE SHEATH WAS ADVANCED TO THE SUPERIOR VENA CAVA (SVC) THE GUIDEWIRE WAS PULLED TO WIPE AWAY THROMBUS. WHEN THE RETROGRADE BLOOD FLOW WAS DRAWN FROM THE INTEGRATED DILATOR/NEEDLE AIR CONTINUED TO BE ASPIRATED. THE INTEGRATED DILATOR/NEEDLE WAS REPLACED. THE SAME PHENOMENON OCCURRED. THE CASE WAS SWITCHED TO ANOTHER MANUFACTURER'S PRODUCT AND THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587543 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 106379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...