BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 1985471 · Received February 7, 2011

    Report

    Report Number
    MW5019346
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON DURING PROCEDURE IN (B)(6) DID NOT DEFLATE. REQUIRED INFLATION TO BURST THE BALLOON. NO HARM TO PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER DYB ST JUDE MEDICAL 3240640

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR