BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY TWIST

    MDR report key: 23889524 · Received December 24, 2025

    Report

    Report Number
    3014590708-2025-00038
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    September 6, 2023
    Report Date
    December 24, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    QEW
    UDI-DI
    00850032079150
    PMA / PMN Number
    K214114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 8F PRODIGY TWIST WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. THE MANUFACTURING RECORDS CONFIRMED THE PRODUCT MET THE DESIGN, MANUFACTURING, AND QUALITY SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE DISSECTION IS UNKNOWN. THERE WAS NO ALLEGATION AGAINST THE 8F PRODIGY TWIST, AND NO DEVICE ISSUES REPORTED DURING THE PROCEDURE. AS MULTIPLE DEVICES WERE INVOLVED IN THE REPORTED EVENT, A RELATED MDR WAS SUBMITTED FOR THE SAME PATIENT AND INCIDENT UNDER REFERENCE NUMBER 3014590708-2025-00037.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS TREATED USING A THIRD-PARTY SHEATH, 8F PRODIGY CATHETER, AND 8F PRODIGY TWIST. THE CLOT WAS ORGANIZED. A VESSEL DISSECTION WAS DIAGNOSED, WHICH THE PHYSICIAN WAS UNAWARE OF UNTIL THE INITIAL ANGIOGRAM. THE DISSECTION IMPEDED BLOOD FLOW TO THE FOOT. IT WAS DETERMINED THAT THE DISSECTION WAS THE PRIMARY REASON FOR THE LACK OF FLOW AND WAS UNRELATED TO THE CATHETER'S ABILITY TO REMOVE CLOT. IT IS UNKNOWN WHETHER ANY ADDITIONAL INTERVENTION WAS PERFORMED TO ADDRESS THE DISSECTION. THERE WAS NO MALFUNCTION REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531784 PRODIGY TWIST PRODIGY TWIST QEW IMPERATIVE CARE INC. TWIST8F 020697 00850032079150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 8F PRODIGY CATHETER.| TERUMO DESTINATION SHEATH.