BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 4161757 · Received July 24, 2014

    Report

    Report Number
    2020394-2014-00340
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WOULD NOT INFLATE BEYOND 8 ATM AND THEN WOULD NOT DEFLATE. AFTER MANIPULATION, THE BALLOON EVENTUALLY DEFLATED ENOUGH TO BE REMOVED THROUGH THE SHEATH. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433228 CONQUEST PTA BALLOON DILATATION CATHETER DQY DQY BARD PERIPHERAL VASCULAR, INC. REYC1426

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown