BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEEKER CROSSING SUPPORT CATHETER

    MDR report key: 2223332 · Received August 15, 2011

    Report

    Report Number
    2020394-2011-00189
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K103367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS IS UNDERWAY. THE DEVICE WAS DISCARDED BY THE USER FACILITY. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN AN EXTREMELY CALCIFIED ILIAC BIFURCATION, A PORTION OF THE CROSSING SUPPORT CATHETER DETACHED AFTER THE PHYSICIAN APPLIED FORCE DURING RETRACTION. ANOTHER CROSSING SUPPORT CATHETER WAS ADVANCED THROUGH A SECOND ACCESS SITE ON THE OPPOSITE SIDE AND THE DETACHED PORTION WAS REMOVED WITH A SNARE THROUGH THIS SECOND CATHETER, COMPLETING THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEKER CROSSING SUPPORT CATHETER DQY BARD PERIPHERAL VASCULAR, INC. VTVD1368

    Patients

    Seq Age Sex Outcome Treatment
    1