BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POUNCE¿ VENOUS THROMBECTOMY SYSTEM

    MDR report key: 23241387 · Received October 7, 2025

    Report

    Report Number
    3014687026-2025-00005
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 7, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    QEW
    PMA / PMN Number
    K201705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE PV DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE. THE OUTER ADHESIVE FILLET WAS NO LONGER BONDED TO THE OUTER HYPOTUBE AND METAL COLLAR. THE ADHESIVE RESIDUE REMAINED ON THE NOSE CONE ITSELF. THE INNER ADHESIVE TO THE GUIDEWIRE LUMEN (GWL) WAS STILL INTACT.

    Description of Event or Problem · 0

    THE POUNCE VENOUS (PV) DEVICE WAS USED IN A MECHANICAL THROMBECTOMY PROCEDURE. THIS EVENT PERTAINS TO THE USE OF THE INITIAL DEVICE. AFTER SEVERAL PASSES (APPROXIMATELY SEVEN), THE PV DEVICE WAS REMOVED FROM THE PATIENT. DURING BASKET CLEANING, THE NOSE CONE WAS OBSERVED TO BE NO LONGER SECURED TO THE INNER SHAFT. THE NOSE CONE REMAINED ATTACHED TO THE PV DEVICE VIA THE INNER POLYAMIDE TUBING. USE OF THIS DEVICE WAS THEN DISCONTINUED AND THE PROCEDURE WAS COMPLETED WITH THE USE OF A SECOND DEVICE. THERE WAS NO REPORT OF PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565343 POUNCE¿ VENOUS THROMBECTOMY SYSTEM Peripheral mechanical thrombectomy with aspiration QEW SURMODICS, INC. VTS-0018-09010 FG240059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown