BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 23451153 · Received November 3, 2025

    Report

    Report Number
    3012120746-2025-00034
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 9, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00850027837970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: PSCC100 PRODUCT TYPE: CATHETER PRODUCT ID: 10FCC13 PRODUCT TYPE: SHEATH PRODUCT ID: NON- MEDTRONIC PRODUCT PRODUCT TYPE RV CATHETER PRODUCT ID: NON- MEDTRONIC PRODUCT PRODUCT TYPE ICE CATHETER PRODUCT ID: NON- MEDTRONIC PRODUCT PRODUCT TYPE GUIDEWIRE 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: NON-MEDTRONIC PRODUCT TYPE: INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER PRODUCT ID: NON-MEDTRONIC PRODUCT TYPE: CATHETER PRODUCT ID: NON-MEDTRONIC PRODUCT TYPE: GUIDEWIRE PRODUCT ID: NON-MEDTRONIC PRODUCT TYPE: SHEATH PRODUCT ID: NON-MEDTRONIC PRODUCT TYPE: 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.

    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 POST PULSED FIELD ABLATION PROCEDURE, THE PATIENT UNDERWENT PRE-PROCEDURAL INTRACARDIAC ECHOCARDIOGRAPHY IMAGING, WHICH REVEALED NO EFFUSIONS PRIOR TO THE PROCEDURE. THE PATIENT WAS INTUBATED, AND PREPPED IN THE USUAL MANNER. VENOUS AND ARTERIAL ACCESS WAS OBTAINED, AND CATHETERS WERE POSITIONED, INCLUDING A NON MEDTRONIC RIGHT VENTRICULAR LEAD CATHETER AND NON MEDTRONIC INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. TRANSSEPTAL ACCESS WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GUIDANCE WITHOUT ISSUE USING AN INTEGRATED DILATOR AND SHEATH. ABLATION WAS INITIATED WITH THE PULSESELECT CATHETER, AND AFTER THE THIRD ABLATION ON THE RIGHT SUPERIOR, A BRIEF PERIOD OF BRADYCARDIA OCCURRED; STAFF PACED THE PATIENT AND ADMINISTERED 0.5 MG ATROPINE, RESULTING IN NORMALIZATION OF HEART RATE. ABLATION WAS COMPLETED AND EXIT BLOCK TESTING WAS PERFORMED. THE PULSESELECT CATHETER WASREMOVED, AND AN ANTICOAGULANT ANTAGONIST WAS ORDERED. DURING ROUTINE POST-PROCEDURE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING, A PERICARDIAL EFFUSION MEASURING 1.2 CM WAS NOTED. ALL CATHETERS WERE REMOVED, AND A POST-PROCEDURE TRANSTHORACIC ECHOCARDIOGRAM SHOWED ACTIVE GROWTH OF THE EFFUSION TO 2 CM. THE PHYSICIAN PERFORMED PERICARDIOCENTESIS, REMOVING 400 ML OF BLOOD AND LEAVING A PERICARDIAL DRAIN IN PLACE. THE PATIENT WAS TRANSPORTED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) WITH 200 ML LEFT IN THE DRAIN, INTUBATED, AND WITH AN ARTERIAL LINE FOR MONITORING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PHYSICIAN INDICATED THAT THE ISSUE LIKELY DEVELOPED DUE TO CATHETER MANIPULATION, WITH A PUNCTURE OF THE RIGHT VENTRICULAR LEAD PROBABLY FROM THE PACING CATHETER. THE EVENT LED TO AN EXTENSION OF THE PATIENT¿S HOSPITALIZATION. THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT LOST ONE LITER OF BLOOD. THE PATIENT THEN UNDERWENT SURGERY TO REPAIR A PERFORATION IN THE RIGHT VENTRICULAR (RV) APEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5481 FLEXCATH CROSS TRANSSEPTAL SOLUTION INTRODUCER, CATHETER DYB ACUTUS MEDICAL INC 900310 107069 00850027837970

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R SEE H11| SEE H11...