BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXCATH CROSS TRANSSEPTAL SOLUTION

    MDR report key: 20700027 · Received November 15, 2024

    Report

    Report Number
    3012120746-2024-00021
    Event Type
    Death
    Date Received
    November 15, 2024
    Date of Event
    October 8, 2024
    Report Date
    January 29, 2025
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    UDI-DI
    00850027837833
    PMA / PMN Number
    K233691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6. DEVICE NOT DISTRIBUTED IN THE US. THE DEVICE IN QUESTION HAS BEEN DISCARDED AND IS UNAVAILABLE FOR INVESTIGATION. NO NONCONFORMANCES WERE FOUND AFTER AN ANALYSIS OF PRODUCTION RECORDS. PER PHYSICIAN FOLLOW-UP, THE EVENT WAS NOT DEEMED TO BE PRODUCT RELATED. PHYSICIAN AND A SECOND INDEPENDENT PHYSICIAN EXAMINED THE DEVICE AND FOUND NO VISUAL OR FUNCTIONAL ABNORMALITIES. A ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED IN THIS CASE; HOWEVER, THE INSTRUCTIONS FOR USE (IFU) PROVIDES GUIDANCE ON STEPS ONCE RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OF FLEXCATH CROSS. RISK CONTROL FOR THE FAULT MODE: "UNABLE TO ADVANCE GUIDEWIRE TO REQUIRED POSITION" WITH POTENTIAL PATIENT HARM: "ACCESS SITE COMPLICATIONS" REFERS TO THE IFU. ACCESS SITE COMPLICATIONS ARE A POTENTIAL CLINICAL RISK ASSOCIATED WITH THE USE OF THE FLEXCATH CROSS DEVICE, WHICH IS THE SAME AS THE RISK OF A PROCEDURE PERFORMED WITH SIMILAR, COMPETITIVE DEVICES.

    Additional Manufacturer Narrative · 0

    DEVICE NOT DISTRIBUTED IN THE US. THE DEVICE IN QUESTION HAS BEEN DISCARDED AND IS UNAVAILABLE FOR INVESTIGATION. NO NON-CONFORMANCES WERE FOUND AFTER AN ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS AND CONCLUSIONS PENDING ADDITIONAL INFORMATION AND WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE WHEN THE SHEATH AND INTEGRATED DILATOR/NEEDLE WERE ADVANCED THROUGH THE GROIN, RESISTANCE WAS FELT. THE PHYSICIAN INITIALLY TRIED TO PUSH THE FLEXCATH CROSS SYSTEM FORWARD, BUT WAS UNSUCCESSFUL. THE GUIDEWIRE WAS REMOVED AND WAS NOTED TO BE BENT. A NEW GUIDEWIRE, ABBOTT GUIDERIGHT/SUPER STIFF, WAS INSERTED AND RESISTANCE WAS FELT AGAIN. THE GUIDEWIRE WAS REPLACED WITH A SECOND ABBOTT GUIDERIGHT/SUPER STIFF AND THE SHEATH WAS ALSO REPLACED WITH AN ABBOTT SL1. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED, AND THEN THE SEDATION WAS REDUCED. THE PATIENT'S CIRCULATION BECAME UNSTABLE AND A VASOPRESSOR DRUG WAS ADMINISTERED. THE GROIN WAS EXAMINED WITH AN ULTRASOUND, AND A GROIN BLEED WAS DETECTED. A VASCULAR SURGEON ATTEMPTED TO CLOSE THE PUNCTURE SITE WITH A BALLOON, BUT IT WAS UNSUCCESSFUL. THE CASE WAS ABORTED. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. REANIMATION MEASURES WHICH INCLUDED CARDIOPULMONARY RESUSCITATION (CPR) WERE UNSUCCESSFUL AND THE PATIENT DIED IN THE CARDIAC CATHETERIZATION LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308012 FLEXCATH CROSS TRANSSEPTAL SOLUTION TRANSSEPTAL INTEGRATED DILATOR/NEEDLE DRE ACUTUS MEDICAL, INC. 900304 105758 00850027837833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death ABBOTT GUIDERIGHT/SUPER STIFF GUIDEWIRE| ABBOTT SL1 SHEATH