BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23498471 · Received November 7, 2025

    Report

    Report Number
    3012120746-2025-00037
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00763000935504
    PMA / PMN Number
    K233691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 10FCC20 (0012508341); PRODUCT TYPE: SHEATH PRODUCT ID PSCC100 (0012630480); PRODUCT TYPE: CATHETER 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.

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION A: PATIENT IDENTIFIER. 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 PULSE FIELD ABLATION PROCEDURE, THE DILATOR WAS PUSHED OUT OF THE SHEATH WHEN ATTEMPTING TO ADVANCE INTO THE RIGHT FEMORAL VEIN, AND WAS SUBSEQUENTLY REPOSITIONED WITH FLUOROSCOPIC GUIDANCE TO COMPLETE ENTRY. ANOTHER MANUFACTURER'S GUIDEWIRE FELT STUCK BUT WAS EVENTUALLY FREED. THE GUIDEWIRE DEVELOPED A KINK AND WAS REPLACED WHILE THE TRANSEPTAL SYSTEM WAS IN THE RIGHT ATRIUM. CARDIOVERSION WAS PERFORMED PRIOR TO COLLECTING VOLTAGE AND THE PATIENT HAD AN ONSET OF TRANSIENT ST ELEVATION. A VASODILATOR WAS ADMINISTERED AND A MILD CHANGE IN THE ST ELEVATION WAS NOTED, FOLLOWED BY RESOLUTION. THE PATIENT'S PREVIOUS EKG NOTED A CHRONIC BASELINE ST ELEVATION. PRIOR TO POST MAPPING, ONLY THE SHEATH AND ANOTHER MANUFACTURER'S MAPPING CATHETER REMAINED IN THE PATIENT. ADDITIONALLY, A HEMATOMA WAS NOTED WHEN THE SHEATH WAS REMOVED AT THE END OF THE PROCEDURE, WHICH WAS RESOLVED WITH APPLIED PRESSURE. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. THE PATIENT WAS MONITORED OVERNIGHT. IT WAS NOTED THAT THE PATIENT STILL HAD ST ELEVATION AND HAD DEVELOPED PERICARDITIS FROM THE ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESU LT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT EXTENDED HOSPITALIZATION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180933 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 106667 00763000935504

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R SEE H11.