BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY IMAGING CATHETER

    MDR report key: 3016714 · Received March 19, 2013

    Report

    Report Number
    3004672267-2013-00001
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NQQ
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AND THE LOT NUMBER OF THE DEVICE IS UNAVAILABLE. IMAGES HAVE BEEN REQUESTED FROM THE FACILITY.

    Description of Event or Problem · 1

    THE DRAGONFLY IMAGING CATHETER WAS USED TO EVALUATE THE PLACEMENT OF A STENT. UPON REMOVAL OF THE DRAGONFLY IMAGING CATHETER, THE PHYSICIAN STATED THAT THE DRAGONFLY IMAGING CATHETER GOT CAUGHT IN THE STENT. THE PHYSICIAN STATED HE USED THE GUIDEWIRE TO DISLODGE THE DRAGONFLY IMAGING CATHETER. THE GUIDEWIRE BECAME PROLAPSE AND GOT STUCK IN THE STENT. THE GUIDEWIRE WAS REMOVED BUT THE STENT WAS DAMAGED. DUE TO A MODERATE FLOW DISTURBANCE THE PHYSICIAN PLACED ANOTHER STENT IN THE PATIENT. FLOW IMPROVED AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114257 DRAGONFLY IMAGING CATHETER INTERVASCULAR IMAGING CATHETER NQQ ST. JUDE MEDICAL 13751-05 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention