BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE¿ VENOUS THROMBECTOMY SYSTEM

    MDR report key: 21843015 · Received April 15, 2025

    Report

    Report Number
    3014687026-2025-00001
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 15, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    QEW
    PMA / PMN Number
    K201705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE. A BASKET WIRE NEAR THE DISTAL NOSE CONE WAS BROKEN. THE CAUSE OF THE THROMBUS MIGRATION WAS NOT RELATED TO THE REPORTED MALFUNCTION OF BASKET WIRE FRACTURE.

    Description of Event or Problem · 0

    THE POUNCE VENOUS (PV) DEVICE WAS USED IN CONJUNCTION WITH THE 12FR POUNCE SHEATH. ACCESS WAS GAINED THROUGH THE LEFT POPLITEAL VEIN. AN 0.018" GUIDEWIRE WAS INTRODUCED WITH A 5FR CATHETER. VENOUS ANGIOGRAPHY WAS THEN PERFORMED, WHICH REVEALED VENOUS THROMBUS FROM THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL ACCESS SITE. THE CATHETER WAS REMOVED AND THE POUNCE VENOUS THROMBECTOMY SYSTEM WAS PREPPED AND INSERTED OVER THE 0.018" GUIDEWIRE TO THE COMMON FEMORAL VEIN. THE DELIVERY SHEATH WAS PULLED BACK AND BASKET WIRE WAS EXPOSED AND EXPANDED. A VENOGRAM OF THE ILIAC AND DISTAL INFERIOR VENA CAVA (IVC) WAS PERFORMED THROUGH THE PV DEVICE SIDE ARM. IT WAS DETERMINED THERE WAS NO APPARENT THROMBUS AT THE ILIAC STENT AND IVC FILTER. AFTER THE FIRST PV PASS AND DEVICE REMOVAL, THERE WAS A MIXTURE OF BLOOD AND THROMBUS NOTED IN THE COLLECTION BAG WITH MODERATE THROMBUS ON THE PV BASKET. THE CATHETER WAS REINSERTED, AND VENOGRAPHY SHOWED THE PROXIMAL TO MID FEMORAL VEIN WAS CLEAR OR THROMBUS. HOWEVER, THROMBUS REMAINED IN THE DISTAL FEMORAL TO POPLITEAL ACCESS SITE. THE PV DEVICE WAS CLEANED, RE-SHEATHED AND RE-INTRODUCED INTO THE PROXIMAL FEMORAL VEIN. THE BASKET ASSEMBLY WAS UNSHEATHED AND EXPANDED INTO POSITION. VENOGRAM WAS PERFORMED THROUGH THE PV DEVICE SIDE ARM AND IT WAS DETERMINED THE THROMBUS HAD MIGRATED TO THE ILIAC STENT AND IVC FILTER. THE DECISION WAS MADE TO CONTINUE THE SECOND PASS WITH THE PV DEVICE WITH DRIVE MOTOR ON IN ATTEMPT TO CAPTURE AND PREVENT ANY FURTHER THROMBUS MIGRATION FROM THE FEMORAL POPLITEAL VEIN. THE PV DEVICE WAS REMOVED WITH MINIMAL THROMBUS NOTICED ON THE BASKET. THE CATHETER WAS RE-INTRODUCED AND THE RESULTANT VENOGRAM DEMONSTRATED DIFFUSE THROMBUS EXTENDING FROM THE POPLITEAL TO DISTAL IVC. UPON CLEANING AND INSPECTION OF THE PV DEVICE THE SCRUB TECH NOTICED BASKET WIRES HAD BEEN DISLODGED FROM THE NOSE CONE OF THE PV DEVICE. THE DECISION WAS MADE TO COMPLETE THE PROCEDURE WITH A COMPETITOR DEVICE AND THE SUBSEQUENT THROMBECTOMY WAS PERFORMED SUCCESSFULLY. FINAL VENOGRAPHY DEMONSTRATED NO RESIDUAL THROMBUS AND THE 12FR POUNCE SHEATH WAS REMOVED AND FIGURE SUTURE WAS PERFORMED FOR CLOSURE. THE PATIENT RECOVERED IN IR HOLDING WITH NO CLINICAL SEQUELA AND WAS DISCHARGED LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112194 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 Other