BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C7 DRAGONFLY IMAGING CATHETER

    MDR report key: 2499487 · Received March 16, 2012

    Report

    Report Number
    3004672267-2012-00001
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 6, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    NQQ
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF OUR INVESTIGATION ARE INCONCLUSIVE SINCE NO DEVICE WAS RETURNED TO SJM FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED ALL MFG PROCESSES WERE COMPLETED AND THE DEVICE WAS MFG IN ACCORDANCE WITH SJM SPECIFICATIONS. THE CAUSE OF THE FIBER BEING CAUGHT AT THE JUNCTIN OF THE TWO STENTS REMAINS UNK; HOWEVER, INFO INDICATED THE STENT BECAME STUCK DURING THE SECOND PULLBACK AND THE STENT STRUTS WERE NOT FLUSHED IN THE CALCIFIED ARTERY.

    Description of Event or Problem · 1

    THE FIBER BECAME BLOCKED AT THE JUNCTION OF TWO STENTS THAT HAD JUST BEEN DEPLOYED IN A PT WITH A HEAVILY CALCIFIED ARTERY. ANGIOGRAPHIC IMAGES SHOWED THE BLOCKAGE WAS IN A MESH STENT, AT THE PROXIMAL PORTION OF THE MONORAIL SECTION OF THE FIBER. SURGERY WAS PERFORMED TO REMOVE THE FIBER AND THE PT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C7 DRAGONFLY IMAGING CATHETER INTRAVASCULAR IMAGING CATHETER NQQ ST JUDE MEDICAL 13751-02 DF-11-709

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R