BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 3955152 · Received July 15, 2014

    Report

    Report Number
    2020394-2014-00320
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MFR FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POST-DILATATION OF A STENT IN THE ILIAC VEIN, THE PTA BALLOON RUPTURED AND DETACHED INTO TWO SEGMENTS. THE DISTAL END OF THE BALLOON AND THE DISTAL TIP OF THE CATHETER THEN GOT STUCK WITHIN THE VEIN. A SURGICAL PROCEDURE WAS PERFORMED TO RETRIEVE THE DETACHED SEGMENT. THE CURRENT STATUS OF THE PT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413093 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. REYA0973

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention