BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 22931984 · Received September 2, 2025

    Report

    Report Number
    3012120746-2025-00027
    Event Type
    Death
    Date Received
    September 2, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 1, 2025
    Manufacturer
    ACUTUS MEDICAL INC
    Product Code
    DYB
    UDI-DI
    00850027837970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE THE PATIENT PASSED AWAY. IT WAS NOTED THAT THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE AND A SUDDEN DECREASE IN OXYGEN SATURATION, WHILE ABLATING IN THE RIGHT SUPERIOR PULMONARY VEIN. THE PATIENT SUBSEQUENTLY EXPERIENCED A CARDIAC ARREST, NECESSITATING CARDIOPULMONARY RESUSCITATION MEASURES. INTRACARDIAC ECHOCARDIOGRAM SHOWED A SIMILAR BASELINE EFFUSION PRIOR TO ABLATION, AND AN ECHOCARDIOGRAM PERFORMED BY THE ANESTHESIA, REVEALED A LARGE RIGHT VENTRICULAR CLOT. ACTIVATED CLOTTING TIME WAS MEASURED MULTIPLE TIMES, WITH RESULTS OF 190, 211, AND 186. THE PATIENT RECEIVED 15,000 UNITS OF HEPARIN, FOLLOWED BY ADDITIONAL DOSES OF ANTICOAGULANT, MULTIPLE ROUNDS OF EPINEPHRINE, BICARBONATE, AND ANTICHOLINERGIC MEDICATIONS. AN IMPELLA DEVICE WAS INSERTED INTO THE LEFT VENTRICLE. DESPITE RESUSCITATION EFFORTS FOR ONE HOUR, THE PATIENT COULD NOT BE REVIVED AND EXPIRED ON THE TABLE. THE PHYSICIAN ATTRIBUTED THE EVENT TO A LARGE PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866083 FLEXCATH CROSS TRANSSEPTAL SOLUTION Introducer, catheter DYB ACUTUS MEDICAL INC 900310 106645 00850027837970

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death