BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POUNCE¿ THROMBECTOMY SYSTEM

    MDR report key: 13501482 · Received February 9, 2022

    Report

    Report Number
    3014687026-2022-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 14, 2022
    Report Date
    February 9, 2022
    Manufacturer
    SURMODICS, INC
    Product Code
    QEW
    UDI-DI
    00812339030296
    PMA / PMN Number
    K192814
    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

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

    Description of Event or Problem · 0

    THE EVENT WAS DESCRIBED AS THE BASKET PARTIALLY BREAKING WHEN BEING PULLED BACK THROUGH A STENTED LESION. THE BASKET CAUGHT ON PART OF THE STENT AND FORCE HAD TO BE USED TO DISLODGE THE BASKET FROM THE STENT. ANY BREAKING OF THE BASKET COULD LEAD TO SHARP EDGES ON THE BASKET WHICH MAY LEAD TO VESSEL DAMAGE OR PERFORATION. THIS PROCEDURE WAS PERFORMED OFF-LABEL AS THE IFU FOR POUNCE HAS A SPECIFIC WARNING NOT TO USE THE DEVICE IN VESSELS THAT HAVE BEEN STENTED. THE DEVICE WAS ALSO USED FOR 6 PASSES, OVER THE LIMIT OF 3 ALLOWED BY THE IFU. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50238 POUNCE¿ THROMBECTOMY SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW SURMODICS, INC PTS-0607-7F135 00812339030296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown