BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRUITT-INAHARA CAROTID SHUNT

    MDR report key: 322943 · Received March 28, 2001

    Report

    Report Number
    MW1021472
    Event Type
    Death
    Date Received
    March 28, 2001
    Date of Event
    March 15, 2001
    Manufacturer
    IDEAS FOR MEDICINE
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN INSERTED THE INTERNAL CAROTID SHUNT INTO THE COMMON CAROTID ARTERY AND THE COMMON CAROTID SHUNT INTO THE INTERNAL CAROTID ARTERY. WHEN THE BALLOON WAS INFLATED IT RUPTURED THE INTERNAL CAROTID AT THE BASE OF THE SKULL. SUGGEST COLOR CODING THE ENDS OF THE SHUNTS AND PUTTING A PRESSURE RELEASE ON THE COMMON CAROTID SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13749 PRUITT-INAHARA CAROTID SHUNT CAROTID SHUNT, OUTLYING, MODEL DQR IDEAS FOR MEDICINE 400-40-9F 1021999-11

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death