BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONQUEST 40 PTA BALLOON DILATATION CATHETER

    MDR report key: 3122525 · Received May 16, 2013

    Report

    Report Number
    2020394-2013-00156
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K120660
    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 UNK. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DURING POST-DILATATION OF A STENT, THE FIBERS FROM THE PTA BALLOON BECAME ENTANGLED IN THE STENT. AFTER SEVERAL ATTEMPTS AT REMOVAL; THE FIBERS RELEASED AND THE PTA DEVICE WAS FULLY RETRACTED WITHOUT FURTHER INCIDENT. REPORTEDLY, DURING REMOVAL ATTEMPTS, THE STENT BEGAN TO MOVE AND AN ADDITIONAL VASCULAR STENT WAS DEPLOYED. THE PT WAS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216868 CONQUEST 40 PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention