BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE ¿ THROMBECTOMY

    MDR report key: 23438340 · Received October 31, 2025

    Report

    Report Number
    3014687026-2025-00006
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 31, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    QEW
    UDI-DI
    00812339030784
    PMA / PMN Number
    K220501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE POUNCE ARTERIAL DEVICE WAS RETURNED FOR ANLAYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE. THE FUNNEL WITH THE BASKETS WERE STILL ON THE BASKET WIRE. THE FUNNEL AND BASKET WIRE WERE CUT JUST PROXIMAL TO THE FUNNEL BRAID BOND AND FUNNEL SHAFT. THE REMAINING FUNNEL SHAFT WAS STILL IN THE FUNNEL CATHETER. THE FUNNEL SHAFT APPEARED TO HAVE FRACTURE WITHIN THE DEVICE HANDLE. THERE WAS CLUMPS OF HIGHLY ORGANIZED CLOT DRIED WITHIN THE FUNNEL AND ATTACHED TO THE BASKETS.

    Description of Event or Problem · 0

    THE POUNCE ARTERIAL MID-PROFILE (MP) DEVICE WAS USED DURING A PERIPHERAL THROMBECTOMY PROCEDURE VIA LEFT FEMORAL ARTERY ACCESS TO TREAT THROMBUS EXTENDING FROM THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH THE DISTAL SFA INTO THE POPLITEAL ARTERY, ESTIMATED AT APPROXIMATELY 50-60 CM IN LENGTH. THE PHYSICIAN HAD NOT PREVIOUSLY USED THE POUNCE SYSTEM AND HAD NOT RECEIVED FORMAL IN-SERVICE TRAINING PRIOR TO THIS CASE. DURING THE FIRST THROMBECTOMY PASS, RESISTANCE WAS ENCOUNTERED AND THE FUNNEL CATHETER AND BASKETS BECAME ENTRAPPED WITHIN A 7 FR, 55 CM SHEATH. ATTEMPTS WERE MADE TO WITHDRAW THE DEVICE AND SHEATH EN BLOC; HOWEVER, SEPARATION OF THE FUNNEL CATHETER SHAFT IN THE DEVICE HANDLE OCCURRED. THE ISSUE WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE AFTER THESE EVENTS HAD ALREADY OCCURRED. CLOT OVERBURDEN WAS SUSPECTED AS THE PHYSICIAN TRIED TO REMOVE THE ENTIRE CLOT WITH ONE PASS. NO FURTHER TROUBLESHOOTING MANEUVERS SUCH AS ASPIRATION, REVERSE LOADING, OR CONTROLLED ROTATION WERE ATTEMPTED PRIOR TO ESCALATION. SURGICAL INTERVENTION WAS REQUIRED, INCLUDING A RIGHT FEMORAL ARTERIAL CUTDOWN FOR DEVICE RETRIEVAL. ALL COMPONENTS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING FOGARTY EMBOLECTOMY, FOLLOWED BY SURGICAL REPAIR OF THE RIGHT FEMORAL ACCESS AND PERCUTANEOUS CLOSURE OF THE LEFT ACCESS SITE. THE TOTAL PROCEDURAL DELAY WAS APPROXIMATELY 90 MINUTES. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085803 POUNCE ¿ THROMBECTOMY Peripheral mechanical thrombectomy with aspiration QEW SURMODICS, INC. PTS-0607-7F135 FG240003 00812339030784

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention