BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 3961166 · Received May 28, 2014

    Report

    Report Number
    2020394-2014-00241
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A RECANALIZATION CATHETER, BEING USED TO TREAT A CTO IN THE POSTERIOR TIBIAL ARTERY, DETACHED WHILE THE CATHETER WAS BEING REMOVED FROM THE PT AND WAS UNABLE TO BE RETRIEVED. THERE WAS NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314933 CROSSER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFXJ0877

    Patients

    Seq Age Sex Outcome Treatment
    1