BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POUNCE VENOUS THROMBECTOMY SYSTEM

    MDR report key: 23732649 · Received December 5, 2025

    Report

    Report Number
    3014687026-2025-00007
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 5, 2025
    Manufacturer
    SURMODICS INC.
    Product Code
    QEW
    UDI-DI
    00812339030791
    PMA / PMN Number
    K201705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION INCLUDED UTILIZING A POUNCE VENOUS DEVICE WITH A SIMULATED USE MODEL WITH LAB MADE CLOT. THE FAILURE MODE COULD NOT BE REPLICATED AFTER 4 PASSES THROUGH A CLOSED 12FR POUNCE SHEATH HEMOSTASIS VALVE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONFIRMED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE POUNCE VENOUS DEVICE WAS USED TO TREAT A PATIENT'S LOWER LEG EXTREMITY WITH SUB-ACUTE/CHRONIC MORPHOLOGY WITH NO SIGNIFICANT TORTUOSITY. IT WAS REPORTED THAT AFTER 3-4 PASSES, UPON REMOVAL OF THE DEVICE, A PIECE OF THE BASKET HAD SEPARATED FROM THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN DID EXPERIENCE RESISTANCE WHILE WITHDRAWING THE DEVICE FROM THE BODY. DURING THE INVESTIGATION OF THE COMPLAINT, IT WAS CONFIRMED THAT THE PHYSICIAN DID NOT DEFEAT THE HEMOSTASIS VALVE ON THE 12FR POUNCE SHEATH DEVICE WHILE WITHDRAWING THE POUNCE VENOUS DEVICE FROM THE BODY WHICH COULD HAVE CONTRIBUTED TO THE RESISTANCE FELT UPON WITHDRAWAL OF THE DEVICE. THE PHYSICIAN WAS ABLE TO REMOVE THE CLOT WITH A SECOND DEVICE IN CONJUNCTION WITH BALLOON VENOPLASTY. THERE WAS NO REPORTED HARM TO THE PATIENT OR SIGNIFICANT PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876834 POUNCE VENOUS THROMBECTOMY SYSTEM Peripheral mechanical thrombectomy with aspiration QEW SURMODICS INC. VTS-0018-09010 FG250028 00812339030791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown