BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 4780934 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00193
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    November 12, 2014
    Report Date
    January 16, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. THE LOT NUMBER HAS BEEN PROVIDED AND THE LOT DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS LOT NUMBER AND ISSUE TO DATE. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR A COMPLETE CIRCUMFERENTIAL OUTER CATHETER BREAK, AT THE PROXIMAL BUTT JOINT. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BROKE AT THE PROXIMAL JOINT WHICH WAS NOTICED AFTER THE SECOND INFLATION/RETRACTION IN THE RIGHT AVF FOREARM. THERE WAS NO DIFFICULTY RETRACTING THROUGH THE SHEATH AND NO FURTHER TREATMENT WAS NECESSARY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252974 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93FY0128

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR