BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY IMAGING CATHETER

    MDR report key: 2756297 · Received September 19, 2012

    Report

    Report Number
    3004672267-2012-00006
    Event Type
    Injury
    Date Received
    September 19, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NKK
    PMA / PMN Number
    K098357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED AND THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO SJM SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE PHYSICIAN STATED THAT THE CONTRAST FLUSHING CAUSED THE FIBRILLATION.

    Description of Event or Problem · 1

    PHYSICIAN DID TWO OCT PULLBACKS ON THE LAD VESSEL OF THE PATIENT. RIGHT AFTER THE SECOND RUN, PATIENT SUFFERED VENTRICULAR FIBRILLATION. CPR WAS ADMINISTERED AND PATIENT WAS RESUSCITATED, WITH NO FURTHER EVENT. THE PHYSICIAN ALLEGED THAT THE FLUSHING OF CONTRAST MEDIUM DURING THE PULLBACK CAUSED THE EVENT, AS THE VESSEL WAS DEPRIVED OF BLOOD FOR A BRIEF PERIOD OF TIME AND THUS BECAME ISCHAEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGONFLY IMAGING CATHETER INTERVASCULAR IMAGING CATHETER NKK ST. JUDE MEDICAL 13751-02 DF-11-771

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention