BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDELINER V2 CATHETER

    MDR report key: 3190366 · Received June 26, 2013

    Report

    Report Number
    2134812-2013-00019
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 24, 2013
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DQY
    PMA / PMN Number
    K112082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED INABILITY TO ADVANCE TWO STENTS THROUGH PROXIMAL OPENING OF GUIDELINER GUIDE EXTENSION CATHETER. A STENT CAME OFF THE DELIVERY BALLOON AND WAS SUCCESSFULLY RETRIEVED. THE PHYSICIAN REPORTED GUIDELINER PROXIMAL OPENING LOOKED FINE UPON REMOVAL OF THE CATHETER. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289617 GUIDELINER V2 CATHETER CATHETER DQY VASCULAR SOLUTIONS, INC. 5571 564118

    Patients

    Seq Age Sex Outcome Treatment
    1