BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 3210066 · Received June 27, 2013

    Report

    Report Number
    2020394-2013-00187
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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 SAMPLE HAS BEEN RETURNED TO THE MFR FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PCA BALLOON WAS DIFFICULT TO INFLATE AND DEFLATE DURING USE ON THE CEPHALIC ARCH. REPORTEDLY, AT INFLATION, ONLY THE PROXIMAL HALF OF THE BALLOON WOULD INFLATE. THEN DURING DEFLATION, IT TOOK SEVERAL ATTEMPTS TO GET THE BALLOON TO DEFLATE. THERE WERE NO RETRACTION ISSUES. ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292145 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. REXB1970

    Patients

    Seq Age Sex Outcome Treatment
    1