BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE¿ THROMBECTOMY SYSTEM

    MDR report key: 16873286 · Received May 4, 2023

    Report

    Report Number
    3014687026-2023-00004
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 4, 2023
    Manufacturer
    SURMODICS INC
    Product Code
    QEW
    UDI-DI
    00812339030296
    PMA / PMN Number
    K192814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: TO DATE, THE DEVICE HAD NOT BEEN RETURNED. IF RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED FOR ANALYSIS RESULTS.

    Description of Event or Problem · 0

    THE ARTERIAL THROMBECTOMY DEVICE WAS BEING USED IN A SUPERFICIAL FEMORAL ARTERY (SFA) PROCEDURE. THE SURGEON MADE TWO PASSES WITH A COMPETITOR GUIDEWIRE IN ORDER TO CROSS THE LESION WITH MINIMAL RESISTANCE. THE DEVICE WAS DEPLOYED IN THE PROXIMAL SFA AND THE DEVICE FUNNEL HAD A "FUNNY TWISTED" SHAPE ON IMAGING. IT WAS THOUGHT THE FUNNEL WAS DEPLOYED IN TO THE LESION OR CHRONIC MATERIAL. THE FUNNEL WAS RE-SHEATHED AND PULLED BACK AND REDEPLOYED. THE FUNNEL THEN DEPLOYED TO THE EXPECTED SHAPE. UPON DEVICE REMOVAL AFTER THE INITIAL PASS, SOME CHRONIC MATERIAL WAS IN THE BASKET AND FUNNEL. THE DEVICE WAS REMOVED WITH MINIMAL RESISTANCE. ONCE OUT, THE TIP OF THE BASKETWIRE WAS ENTANGLED WITH THE FUNNEL, WHICH WAS ABLE TO BE EASILY FREED BY PULLING THE BASKETWIRE FURTHER INTO THE FUNNEL SO THE BASKETWIRE TIP CLEARED THE TIP OF THE FUNNEL. AN ANGIOGRAM WAS TAKEN AND THE VESSEL "LOOKED WORSE" THAN THE PREVIOUS IMAGE TAKEN PRIOR TO GUIDEWIRE CROSSING. THE SURGEON BELIEVED THE VESSEL WAS DISSECTED AND THEY WERE UNABLE TO CROSS THE LESION INTO THE TRUE LUMEN SPACE FROM THIS ACCESS POINT. THE SURGEON THEN OBTAINED PEDAL ACCESS INTO WHAT WAS THOUGHT TO BE THE TRUE LUMEN SPACE. THE GUIDEWIRE WAS THEN EXTERNALIZED THROUGH THE INITIAL ACCESS POINT GUIDE SHEATH SO A BALLOON COULD THEN BE PLACED. TWO STENTS WERE THEN EMPLACED. THE PROCEDURE WAS CONSIDERED SUCCESSFUL AND ARTERIAL FLOW WAS RESTORED. THE PATIENT DID NOT EXPERIENCE ANY FURTHER IMPACT. THERE WAS NO PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212482 POUNCE¿ THROMBECTOMY SYSTEM Peripheral mechanical thrombectomy with aspiration QEW SURMODICS INC PTS-0607-7F135 FG220021 00812339030296

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention