BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER 5F (HUG3.0 60)

    MDR report key: 1041148 · Received May 12, 2008

    Report

    Report Number
    1220452-2008-00035
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 8, 2008
    Manufacturer
    MEDTRONIC INC
    Product Code
    DQY
    PMA / PMN Number
    K030779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE SUBJECT DEVICE USED DURING THE CASE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, AN ENGINEERING ANAYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORD WILL NOT BE PERFORMED. DEVICE DISCARDED - NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE A DISSECTION OCCURRED IN THE LEFT MAIN ARTERY. THE GUIDE CATHETER WAS INSERTED INTO THE PT FROM A RADIAL APPROACH. THE PHYSICIAN ADVANCED THE GUIDE CATHETER AND CROSSING THE LEFT VENTRICLE AND PERFORMED DIAGNOSTIC PROCEDURE. THE PHYSICIAN THEN REPOSITIONED THE GUIDE INTO THE RIGHT CORONARY ARTERY AND PERFORMED THE DIAGNOSTIC PROCEDURE. THE PHYSICIAN THEN REPOSITIONED AGAIN INTO THE LEFT MAIN ARTERIAL ARTERY AND WHILE PERFORMING THE DIAGNOSTIC PROCEDURE ON THE VESSEL, A DISSECTION OCCURRED. THE GUIDE CATHETER WAS REMOVED AND A SECOND GUIDE CATHETER WAS INSERTED INTO THE LEFT MAIN; HOWEVER, THE GUIDE CATHETER CHOSEN WAS TOO SHORT. THAT GUIDE CATHETER WAS REMOVED AND ANOTHER GUIDE CATHETER WAS INSERTED AND ADVANCED INTO PLACE. THE PHYSICIAN INSERTED A 3.5X18MM STENT AND SUCCESSFULLY TREATED THE DISSECTION. THE PT IS REPORTED TO BE FINE. THE ACTUAL DEVICE USED DURING THE CASE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUNCHER 5F (HUG3.0 60) DQY MEDTRONIC INC NA 0000698067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention