BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVENTUS THROMBECTOMY SYSTEM

    MDR report key: 24407881 · Received February 20, 2026

    Report

    Report Number
    3031823122-2026-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 20, 2026
    Manufacturer
    INQUIS MEDICAL
    Product Code
    QEW
    PMA / PMN Number
    K251189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS OBSERVED AFTER MULTIPLE ASPIRATIONS WITHOUT REMOVING THE ASPIRATED BLOOD FROM THE CLOT CANISTER, THAT BLOOD WAS EXITING BOTH THE RETURN AND INLET SIDES OF THE ASPIRATION SYRINGE. INQUIS PERSONNEL NOTED THE CLOT CANISTER WAS FILLED WITH BLOOD DUE TO REPEATEDLY MISSING THE WORKSTEP OF DISCONNECTING THE BLOOD RETURN SYRINGE AND IMMEDIATELY RETURNING BLOOD TO THE PATIENT. THE AVENTUS THROMBECTOMY SYSTEM INSTRUCTIONS FOR USE PROVIDES INSTRUCTIONS AND A PRECAUTION TO RETURN BLOOD IMMEDIATELY TO THE PATIENT. FAILURE TO FOLLOW THESE STEPS LED TO AN UNACCEPTABLE LEVEL OF POSITIVE PRESSURE IN THE SYSTEM WHICH LED TO THE VALVE FAILURE.

    Description of Event or Problem · 0

    DURING THE THROMBECTOMY PROCEDURE TO TREAT THE PATIENT'S PULMONARY EMBOLISM A VALVE IN THE AVENTUS THROMBECTOMY SYSTEM SYRINGE FAILED, POTENTIALLY ALLOWING BLOOD TO RETURN TO THE PATIENT VIA THE THROMBECTOMY CATHETER. THIS FAILURE OCCURRED DUE TO REPEATED ASPIRATIONS BEING PERFORMED WITHOUT RELIEVING PRESSURE IN THE SYSTEM BY IMMEDIATELY RETURNING BLOOD TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196033 AVENTUS THROMBECTOMY SYSTEM EMBOLECTOMY CATHETER QEW INQUIS MEDICAL CMS-M 25092908

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female