BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE ¿ THROMBECTOMY

    MDR report key: 20617189 · Received November 6, 2024

    Report

    Report Number
    3014687026-2024-00003
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 7, 2024
    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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE WAS RETURNED FOR ANALYSIS. THE FUNNEL AND INNER CATHETER SHAFT WERE SEPARATED FROM THE DELIVERY CATHETER. THE FUNNEL SEPARATED AT THE INNER SHAFT BOND. THE DAMAGE SUSTAINED WAS CONSISTENT WITH THE REPORT FORCING THE DEVICE THROUGH THE PROCEDURAL SHEATH.

    Description of Event or Problem · 0

    THE DEVICE WAS USED IN A THROMBECTOMY PROCEDURE TO REMOVE SUPERFICIAL FEMORAL ARTERY (SFA) THROMBUS. THE DEVICE MADE A SUCCESSFUL INITIAL PASS WITHOUT INCIDENT. DURING THE SECOND PASS, THE FUNNEL WOULD NOT PASS THROUGH THE TIP OF THE 7FR SHEATH. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE FUNNEL THROUGH THE SHEATH. DURING THE FINAL ATTEMPT TO FORCIBLY REMOVE THE DEVICE, THE FUNNEL BECAME DETACHED FROM INNER WHITE CATHETER. A SURGICAL VESSEL CUTDOWN WAS THEN PERFORMED TO SUCCESSFULLY REMOVE THE DETACHED FUNNEL AND THE WHITE INNER CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PATIENT IMPACT. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF FOUR HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417294 POUNCE ¿ THROMBECTOMY Peripheral mechanical thrombectomy with aspiration QEW SURMODICS INC PTS-0607-7F135 FG230035 00812339030784

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention