BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POUNCE¿ THROMBECTOMY SYSTEM

    MDR report key: 18323584 · Received December 13, 2023

    Report

    Report Number
    3014687026-2023-00007
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 13, 2023
    Manufacturer
    SURMODICS INC
    Product Code
    QEW
    PMA / PMN Number
    K192814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: DEVICE ANALYSIS CONFIRMED THE REPORTED ISSUE. THE BASKET WIRE WAS RETURNED WITH THE PROXIMAL BASKET DETACHED, PROLAPSED, AND OVER THE DISTAL BASKET. THE THREE BASKET STRUTS WERE SEPARATED FROM THE BASKET COLLAR. THE REPORTED ISSUE WAS ATTRIBUTED TO IMPROPER HANDLING AND USE OF THE BASKET WIRE.

    Description of Event or Problem · 0

    THE DEVICE WAS USED DURING A LEFT FEMOROPOPLITEAL SAPHENOUS VEIN GRAFT BYPASS. ONE PASS OF THE DEVICE WAS USED WITHOUT ISSUE. THE SITE ATTEMPTED TO INSERT THE DELIVERY CATHETER FOR A SECOND PASS WITHOUT THE INSERTION TOOL AND IT WAS NOTED THE SECOND (PROXIMAL) BASKET WAS NOT DELIVERY SMOOTHLY. THE SITE THEN STOPPED AND LOADED WITH THE INSERTION TOOL, BUT NOTICED THE SECOND BASKET WAS "MILDLY MALFORMED." THE DEVICE WAS STILL USED TO PERFORM A SECOND PASS. UPON REMOVAL, THE PROXIMAL BASKET WAS COMPLETELY SEPARATED FROM THE BASKET COLLAR, BUT REMAINED ON THE WIRE. THE REPORTED ISSUE DID NOT RESULT IN ANY COMPLICATIONS OR DELAYS. THE PROCEDURE WAS COMPLETED WITH THE USE OF A SECOND DEVICE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780470 POUNCE¿ THROMBECTOMY SYSTEM Peripheral mechanical thrombectomy with aspiration QEW SURMODICS INC PTS-0607-7F135 FG230003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown