BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ZUMA JR40

    MDR report key: 217980 · Received April 7, 1999

    Report

    Report Number
    1220452-1999-00015
    Event Type
    Injury
    Date Received
    April 7, 1999
    Report Date
    March 26, 1999
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC
    Product Code
    DYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE CO THAT DURING THE PROCEDURE AS THE PHYSICIAN ATTEMPTED TO ENGAGE THIS DEVICE, A DISSECITON OF THE RIGHT CORONARY ARTERY REPORTEDLY OCCURRED. NO FURTHER EVENT OR PATIENT INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ZUMA JR40 GUIDING CATHETER DYB MEDTRONIC INTERVENTIONAL VASCULAR, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention