BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 2182103 · Received June 23, 2011

    Report

    Report Number
    2020394-2011-00142
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND A MFG RECORD REVIEW IS BEING PERFORMED. THE SAMPLE HAS BEEN RETURNED AND THE EVALUATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS CRACKED. NO FURTHER INFO WAS PROVIDED. THERE WAS NO REPORT OF INJURY TO THE PT. EVALUATION OF THE RETURNED DEVICE IDENTIFIED A BOND FAILURE AT THE BALLOON/CATHETER BUTT JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93LU0039

    Patients

    Seq Age Sex Outcome Treatment
    1