BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUSHUNT

    MDR report key: 52603 · Received November 25, 1996

    Report

    Report Number
    1713910-1996-00030
    Event Type
    Malfunction
    Date Received
    November 25, 1996
    Date of Event
    October 15, 1996
    Report Date
    November 15, 1996
    Manufacturer
    RESEARCH MEDICAL INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING INSERTION OF A CAROTID SHUNT, WHEN THE MD ATTEMPTED TO INFLATE THE BALLOON, THE BALLOON RUPTURED. THE SHUNT WAS REPLACED WITH NO ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUSHUNT CAROTID SHUNT DQR RESEARCH MEDICAL INC. NA 87316

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention