BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVASC 6.0 MM X 44 MM

    MDR report key: 25223015 · Received May 19, 2026

    Report

    Report Number
    3014498720-2026-00002
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 23, 2026
    Manufacturer
    VESALIO, INC.
    Product Code
    QEW
    UDI-DI
    00851279008514
    PMA / PMN Number
    K201085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THROMBECTOMY OF LOWER LEG (TIBIAL ARTERY) THE PVASC DETACHED FROM THE DELIVERY WIRE WHILE TRYING TO REMOVE DEVICE FROM BODY. LARGE PIECE OF TISSUE (NOT CLOT) WAS TRAPPED BETWEEN THE TIP OF THE PENUMBRA BOLT 7 AND THE PVASC DEVICE. THIS LARGE CHUNK GOT CAUGHT IN THE PVASC AND SINCE IT WAS SOLID AND MUCH LARGER THAN THE BOLT 7 TIP, THE FRICTION AN FORCE CAUSED THE PVASC TO DETACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7809 PVASC 6.0 MM X 44 MM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION, PRODUCT CODE: QEW QEW VESALIO, INC. VP-6044-F3RR 112125D 00851279008514

    Patients

    Seq Age Sex Outcome Treatment
    1