BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIORITYONE

    MDR report key: 19786023 · Received July 19, 2024

    Report

    Report Number
    2243441-2024-00021
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 19, 2024
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    QEZ
    UDI-DI
    04543334177254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE ASPIRATION CATHETER, PRIORITY ONE, WAS USED FOR A THROMBECTOMY. MULTIPLE ATTEMPTS WERE SUCCESSFUL (5-6 TIMES). THERE WAS MORE CLOT DISTALLY, SO THEY ADVANCED THE CATHETER BUT STUCK. WHEN PULLING IT, THE CATHETER'S TIP DISLODGED IN THE LEFT MAIN. AN ATTEMPT TO EXTRACT THE FRAGMENT WAS MADE WITHOUT SUCCESS, THEN IT MIGRATED TO THE THORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033615 PRIORITYONE ASPIRATION THROMBECTOMY CATHETER QEZ TERUMO CLINICAL SUPPLY CO., LTD. UG1602 230700660 04543334177254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other