BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1890534 · Received October 29, 2010

    Report

    Report Number
    2020394-2010-00316
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE IS UNK. THE COMPLAINT SAMPLE WAS DISCARDED BY THE USER FACILITY, THEREFORE, AN EVAL OF THE DEVICE COULD NOT BE PERFORMED. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PTA BALLOON BECAME ENTANGLED AT THE OVERLAP OF TWO STENT GRAFTS PLACED IN THE MID-SUPERIOR FEMORAL ARTERY. REPORTEDLY, UPON REMOVAL OF THE DEVICE, THE BALLOON ELONGATED ONE OF THE STENTS. THE BALLOON DILATATION CATHETER WAS REMOVED WITHOUT FURTHER INCIDENT. ANOTHER STENT WAS PLACED TO RESOLVE THE STENT DEFORMATION. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1