BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POUNCE¿ THROMBUS RETRIEVAL SYSTEM

    MDR report key: 12972630 · Received December 9, 2021

    Report

    Report Number
    3014687026-2021-00001
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 9, 2021
    Report Date
    December 9, 2021
    Manufacturer
    SURMODICS, INC
    Product Code
    QEW
    UDI-DI
    00812339030296
    PMA / PMN Number
    K192814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT SUSTAINED MINOR VESSEL DAMAGE WITH THE REMOVAL OF THE CLOT BASKET, DUE TO THE AGGRESSIVE USE OF THE DEVICE, AS WELL AS THE MECHANICAL AND METAL NATURE OF THE BASKET. NO OTHER PATIENT INJURIES, SERIOUS, OR OTHERWISE WERE REPORTED. THE IFU INCLUDES THE FOLLOWING CONTRAINDICATION."DO NOT DEPLOY IN VESSELS WITH PREVIOUSLY IMPLANTED DEVICES." THERE IS ALSO A WARNING IN THE IFU THAT STATES, "THE BASKET ASSEMBLY IS NOT INTENDED TO BE TORQUED OR ADVANCED WITHOUT THE BASKET DELIVERY CATHETER. THIS MAY CAUSE VESSEL DAMAGE OR COMPROMISED DEVICE FUNCTIONALITY."

    Description of Event or Problem · 0

    FOLLOW-UP REPORT TO SUBMIT ADDITIONAL INFORMATION NOT KNOWN AT TIME OF INITIAL SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870602 POUNCE¿ THROMBUS RETRIEVAL SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW SURMODICS, INC PTS-0607-7F135 00812339030296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown