BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7F ZUMA JR4.0

    MDR report key: 227153 · Received June 11, 1999

    Report

    Report Number
    1220452-1999-00021
    Event Type
    Injury
    Date Received
    June 11, 1999
    Date of Event
    March 30, 1999
    Report Date
    May 28, 1999
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING A PTCA PROCEDURE IN WHICH THE PHYSICIAN ATTEMPTED TO REPAIR A MID LESION IN THE RIGHT CORONARY ARTERY, THE 7F ZUMA JR4.0 PULLED OUT OF THE ARTERY. ALONG WITH THE BALLOON AND GUIDE WIRE. AS THE GUIDE CATHETER WAS BEING REPOSITIONED A RIGHT CORONARY ARTERY DISSECTION OCCURRED. THE DISSECTION SPIRALED DOWN TO THE DISTAL AREA. THE PT WAS SENT TO BYPASS SURGERY, AND IS REPORTED TO BE IN STABLE CONDITION. THE DEVICE IS NOT BEING RETURNED FOR EVAL AS IT HAS BEEN DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7F ZUMA JR4.0 7F ZUMA JR4.0 DYB MEDTRONIC INTERVENTIONAL VASCULAR, INC. ZM7JR40 1599

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR