BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWP CATHETER

    MDR report key: 107352 · Received July 17, 1997

    Report

    Report Number
    1217435-1997-00235
    Event Type
    Malfunction
    Date Received
    July 17, 1997
    Report Date
    June 24, 1997
    Manufacturer
    USCI DIV CR BARD INC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE CO THAT DURING THE PROCEDURE THE BALLOON OF THIS DEVICE FAILED TO REMAIN INFLATED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWP CATHETER ANGIOGRAPHY CATHETER DQO USCI DIV CR BARD INC NA 08BH0070

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN