BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVCORE THROMBECTOMY CATHETER, 6-20MM, 12FR, 80CM

    MDR report key: 24782001 · Received April 3, 2026

    Report

    Report Number
    3020347218-2026-00031
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 3, 2026
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    PMA / PMN Number
    K223609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE DEVICE ANALYSIS A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PERIPHERAL VASCULAR ACCOUNT MANAGER REPORTED THAT THE REVCORE DEVICE WAS USED THROUGH A POTENTIALLY DAMAGED STENT. WHEN THE REVCORE WAS REMOVED FROM THE BODY IT WAS VISIBLY BROKEN. NO INJURY TO THE PATIENT WAS REPORTED. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63018 REVCORE THROMBECTOMY CATHETER, 6-20MM, 12FR, 80CM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 44-101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female