BEUDAMED
    FDA Adverse Event Other Summary report: N

    IDEAS FOR MEDICINE (A CRYOLIFE CO)

    MDR report key: 342796 · Received July 20, 2001

    Report

    Report Number
    MW4003016
    Event Type
    Other
    Date Received
    July 20, 2001
    Date of Event
    June 13, 2001
    Report Date
    June 15, 2001
    Manufacturer
    IDEAS FOR MEDICINE
    Product Code
    DQR
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A CAROTID ENDARTERECTOMY, SHUNT WAS PLACED IN THE LEFT CAROTID ARTERY. HALFWAY THROUGH THE PATCH ANGIOPLASTY THE DISTAL BALLOONS IN THE LEFT INTERNAL CAROTID ARTERY RUPTURED CAUSING BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32846 IDEAS FOR MEDICINE (A CRYOLIFE CO) PRUITT-INHARA CAROTID SHUNT DQR IDEAS FOR MEDICINE 400-40-9F 1082198-03

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other