BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23809843 · Received December 15, 2025

    Report

    Report Number
    3012120746-2025-00041
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00763000935504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    CONTINUATION OF D10: PRODUCT ID 10FCC13 (0012963032); PRODUCT TYPE: 0629-FLEXCATH 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 LATER REPORTED THAT TREATMENT FOR THE PERFORATION WAS PERFORMED USING A STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, AN APPROACH WAS ATTEMPTED FROM THE GROIN USING AN INTEGRATED DILATOR/NEEDLE AND SHEATH, THE INCISION WAS NARROW, SO PRE-DILATION WAS PERFORMED USING ANOTHER MANUFACTURER'S DILATOR. AFTER PRE-DILATION, ANOTHER APPROACH WAS ATTEMPTED FROM THE GROIN TO THE INSIDE OF THE HEART WITH THE INTEGRATED DILATOR/NEEDLE AND SHEATH, BUT ADVANCEMENT FROM THE VEIN TO THE INSIDE OF THE HEART WAS NOT ACHIEVED. FLUOROSCOPY CONFIRMED THAT THE GUIDEWIRE HAD COME OUT. RETROGRADE BLOOD FLOW COULD NOT BE OBTAINED FROM INTEGRATED DILATOR/NEEDLE, AND WHEN ANGIOGRAPHY WAS PERFORMED AT THE SAME SITE, IT WAS CONFIRMED THAT THE DISTAL ENDS OF DILATOR/NEEDLE AND SHEATH WERE OUTSIDE THE COMMON ILIAC VEIN (TOWARD THE BODY SIDE). THE PERFORATION WAS CONFIRMED BY EXTRACORPOREAL ECHO AND INTRACARDIAC ECHO. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS SENT FOR CONTRAST COMPUTERIZED TOMOGRAPHY (CT) IMAGING. IT IS UNKNOWN IF INTERVENTION WAS PERFORMED AND IT IS UNKNOWN IF THE PATIENT'S HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284426 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 106669 00763000935504

    Patients

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