BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 3905013 · Received June 9, 2014

    Report

    Report Number
    2020394-2014-00253
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K092175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 MFR FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECANALIZATION CATHETER TIP WAS FOUND TO BE DETACHED AFTER SUCCESSFUL USE IN THE SFA. IT WAS UNK IF THE TIP WAS DETACHED PRIOR TO USE, DURING USE, OR AFTER USE. THE DETACHED TIP WAS NOT VISIBLE IN THE PT UNDER FLUOROSCOPY. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336251 CROSSER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFXK0296

    Patients

    Seq Age Sex Outcome Treatment
    1