BEUDAMED
    FDA Adverse Event Death Summary report: N

    TURNPIKE CATHETER

    MDR report key: 19268538 · Received May 7, 2024

    Report

    Report Number
    MW5154638
    Event Type
    Death
    Date Received
    May 7, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 3, 2024
    Manufacturer
    ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 2 MM DISTAL TIP OF TELEFLEX TURNPIKE LP 135 MM MICROCATHETER SEPARATED FROM THE BULK OF THE TAPERED TIP DURING PTCA. THE BROKEN TIP MOVED INTO PROXIMAL CIRCUMFLEX AND THERE WERE CONCERNS ABOUT TIP GETTING STUCK IN THE LEFT MAIN. GUIDEWIRE WAS ALSO STUCK; LASER ATHERECTOMY ATTEMPTED TO TRY TO MODIFY THE BROKEN TIP AND RETRIEVE WIRE. SEVERE SLOW FLOW AND PEA RESULTED IN PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752477 TURNPIKE CATHETER CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) 73A2400147

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death