BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CROSS

    MDR report key: 19184468 · Received April 25, 2024

    Report

    Report Number
    3012120746-2024-00007
    Event Type
    Injury
    Date Received
    April 25, 2024
    Report Date
    April 25, 2024
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THROMBUS/THROMBOSIS IS A POTENTIAL CLINICAL RISK ASSOCIATED WITH THE FLEXCATH CROSS DEVICE, WHICH IS THE SAME AS THE RISK OF A PROCEDURE PERFORMED WITH SIMILAR, COMPETITIVE DEVICES. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER CONTACT INFORMATION WAS PROVIDED. IF FURTHER INFORMATION IS MADE AVAILABLE A SUPPLEMENTAL MDR WILL BE SENT.

    Description of Event or Problem · 0

    DURING A CRYO ABLATION PROCEDURE, A CLOT FORMED IN THE LEFT ATRIUM. PATIENT WAS BROUGHT INTO THE ROOM FOR THE PROCEDURE. PATIENT WAS POSITIONED ON TABLE. ENSITE X PATCHES APPLIED PER IFU. ANESTHESIA COMPLETED PREP AND INTUBATION. PATIENT WAS PREPPED AND DRAPED IN USUAL MANNER. LOCAL ANESTHESIA TO RIGHT AND LEFT GROIN. MULTIPLE ACCESS SITES OBTAINED AND DIAGNOSTIC CATHETERS (ABT - SUPREME QUAD / INQUIRY QUAD / VIEWFLEX XTRA) POSITIONED IN THE HIS, RV AND RA SITES. BASELINE ACT OBTAINED AND RESULT WAS 170 SECS. MDT CRYO BALLOON / MDT ACHIEVE CATHETER PREPPED AND INSERTED INTO LA. ENSITE X SYSTEM FINAL SETUP COMPLETED PER IFU. LA GEOMETRY AND PRE-ABLATION VOLTAGE MAPPING STARTED. ACT DRAWN. CLOT VISUALIZED ON ICE AND CONSULT CALLED WHICH CONFIRMED CLOT FORMATION ON ICE. ACT RESULT WAS 310 SEC. TO REMOVE THE CLOT, NEGATIVE PRESSURE WAS APPLIED TO THE MDT FLEXCATH SHEATH AS THE MDT CRYO BALLOON AND MDT ACHIEVE CATHETER WERE SLOWLY WITHDRAWN INTO THE SHEATH AND REMOVED FROM THE LA. ACCESS SITES ATTENDED TO BY LAB STAFF. PROTAMINE WAS NOT ADMINISTERED. ACT DRAWN. ACT RESULT WAS 279 SEC. NO ADDITIONAL COMPLICATIONS WERE DEMONSTRATED. THE PATIENT WAS EXTUBATED AND SENT TO POST-PROCEDURE RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541694 FLEXCATH CROSS INTEGRATED NEEDLE/DILATOR DRE ACUTUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ABBOTT INQUIRY QUADRIPOLAR CATHETER| ABBOTT SUPREME QUADRIPOLAR CATHETER| ABBOTT VIEWFLEX XTRA ICE CATHETER| MEDTRONIC ACHIEVE MAPPING CATHETER| MEDTRONIC CRYOBALLOON| MEDTRONIC FLEXCATH SHEATH