BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIORITY ONE AC

    MDR report key: 19659758 · Received July 1, 2024

    Report

    Report Number
    MW5156932
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 27, 2024
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    QEZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TERUMO PRIORITY ONE AC LOT #221004080: DISTAL TIP SEPARATION OF THE PROXIMAL MARKER BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551162 PRIORITY ONE AC ASPIRATION THROMBECTOMY CATHETER QEZ TERUMO CLINICAL SUPPLY CO., LTD. 221004080

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other