BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 3030639 · Received March 26, 2013

    Report

    Report Number
    2020394-2013-00083
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE SAMPLE IS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER POST-DILATATION OF A VASCULAR STENT, THE PTA BALLOON BECAME CAUGHT WITHIN THE STENT AND DURING REMOVAL OF THE BALLOON, THE STENT FOLDED ON ITSELF. ANOTHER PTA BALLOON WAS USED TO REPOSITION THE STENT AND A STENT GRAFT WAS DEPLOYED WITHIN THE VASCULAR STENT TO COMPLETE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123930 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention