BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 4810759 · Received May 22, 2015

    Report

    Report Number
    2020394-2015-00702
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    September 6, 2013
    Report Date
    September 9, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. A MFG REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS LOT NUMBER AND ISSUE TO DATE. THE DEVICE WAS RETURNED FOR EVAL. THE INVESTIGATION IS CONFIRMED FOR MATERIAL SEPARATION BASED ON THE RETURNED CONDITION OF THE SAMPLE. THE MATERIAL SEPARATION WAS LIKELY PERCEIVED BY THE CUSTOMER AS A DEFORMATION IN THE TIP. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR MATERIAL DEFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 3 MINUTES AND 46 SECONDS OF SUCCESSFUL USE IN THE SFA, THE TIP OF THE RECANALIZATION CATHETER APPEARED TO BEND ONTO THE CATHETER. THE CATHETER WAS RETRACTED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335436 CROSSER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. FCWL10012

    Patients

    Seq Age Sex Outcome Treatment
    1