BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 4811420 · Received May 22, 2015

    Report

    Report Number
    2020394-2015-00711
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    February 3, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW OF THIS EVENT WAS PERFORMED AND IDENTIFIED THE EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR A HOLE IN THE GUIDEWIRE LUMEN JUST UNDERNEATH THE DISTAL METAL TIP AND FOR MATERIAL SEPARATION AS THE OUTER CATHETER HAD SEPARATED FROM THE DISTAL METAL TIP. THE HOLE IN THE LUMEN AND THE MATERIAL SEPARATION RESULTED IN THE REPORTED GUIDEWIRE ISSUES. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFO. IT IS UNK IF PT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. THE INFO PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFO AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADD'L INFO, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE RECANALIZATION CATHETER, THE GUIDE WIRE WAS UNABLE TO ADVANCE THROUGH THE DISTAL TIP OF THE RECANALIZATION CATHETER; THEREFORE, A NEW RECANALIZATION CATHETER WAS PREPPED AND USED SUCCESSFULLY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335482 CROSSER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFXK0297

    Patients

    Seq Age Sex Outcome Treatment
    1