BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWP CATHETER

    MDR report key: 57720 · Received December 19, 1996

    Report

    Report Number
    1217435-1996-00155
    Event Type
    Malfunction
    Date Received
    December 19, 1996
    Report Date
    November 25, 1996
    Manufacturer
    USCI DIV CR BARD, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON OF THIS DEVICE RUPTURED DURING PREP. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWP CATHETER ANGIOGRAPHY CATHETER DQO USCI DIV CR BARD, INC. NA 08HF2052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN