BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER 6F (JL3.5)

    MDR report key: 1050158 · Received May 21, 2008

    Report

    Report Number
    1220452-2008-00040
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT A DISSECTION OF THE CORONARY ARTERY WAS NOTICED DURING THE PROCEDURE. THE PHYSICIAN INSERTED THE GUIDE CATHETER INTO THE PT. THE PHYSICIAN INSERTED AN IVUS CATHETER AND PERFORMED IVUS STUDY. THE PHYSICIAN INSERTED A PRE-DILATATION BALLOON, HOWEVER, IT COULD NOT PASS THROUGH THE GUIDE CATHETER DUE TO HIGH RESISTANCE BETWEEN THEM. THE PHYSICIAN EXCHANGED THE PREDILATATION BALLOON WITH ANOTHER AND PERFORMED THE PREDILATATION ON THE VESSEL. AT SOME POINT. A DISSECTION OF THE VESSEL OCCURRED. THE PHYSICIAN INSERTED DEPLOYED TWO STENTS TO TREAT THE DISSECTION AND CLOSED THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS. THE PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUNCHER 6F (JL3.5) DQY MEDTRONIC VASCULAR NA 0000632058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention