BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE VENOUS THROMBECTOMY SYSTEM

    MDR report key: 19332250 · Received May 16, 2024

    Report

    Report Number
    3014687026-2024-00001
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 16, 2024
    Manufacturer
    SURMODICS INC
    Product Code
    QEW
    UDI-DI
    00812339030319
    PMA / PMN Number
    K201705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G4 510(K) UPDATED TO K201705 FROM K192814.

    Description of Event or Problem · 0

    THE POUNCE VENOUS DEVICE WAS USED IN THE PATIENT'S LEFT AND RIGHT LEGS FOR THROMBECTOMY TREATMENT. A 12FR STANDARD INTRODUCER WAS USED AT BOTH POPLITEAL ACCESS POINTS. APPROXIMATELY FOUR TO FIVE DEVICE PASSES WERE PERFORMED IN THE LEFT LEG BEFORE MOVING TO THE RIGHT LEG. PRIOR TO INSERTION INTO THE RIGHT POPLITEAL ARTERY, THE DEVICE WAS DEEMED ACCEPTABLE FOR FURTHER PASSES. AFTER THE FIRST PASS, THE PHYSICIAN ENCOUNTERED RESISTANCE PULLING THE BASKET BACK INTO THE INTRODUCER SHEATH AND WAS UNABLE TO BRING THE BASKET DOWN SUFFICIENTLY WITH THE HANDLE'S CAM OR REAR SLIDE. UPON ATTEMPT TO RE-SHEATH THE BASKET WITH THE OUTER SHEATH THE BASKET FURTHER DEFORMED, AND IT WAS CONFIRMED THAT THE HANDLE WAS NO LONGER ABLE TO COMMUNICATE WITH THE DISTAL END OF THE DEVICE (INABILITY TO EXPAND/COLLAPSE BASKET). FURTHER ATTEMPTS CAUSED THE MID-SHAFT TO FULLY FRACTURE, SEPARATING THE HANDLE FROM THE DEVICE LEAVING JUST THE SHAFT OF THE DEVICE. SEVERAL ATTEMPTS TO RECAPTURE OR REMOVE THE BASKET WERE UNSUCCESSFUL, ULTIMATELY REQUIRING A VENOUS CUT-DOWN AT THE ACCESS SITE TO REMOVE THE BASKET. THE BASKET/CATHETER WAS SUCCESSFULLY REMOVED, AND IT WAS NOTED THAT THE BASKET WAS PACKED FULL WITH CLOT. PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE YESTERDAY EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634786 POUNCE VENOUS THROMBECTOMY SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW SURMODICS INC VTS-0018-09010 23H034AV 00812339030319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention