BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY IMAGING CATHETER

    MDR report key: 2538934 · Received April 11, 2012

    Report

    Report Number
    3004672267-2012-00003
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    March 8, 2012
    Report Date
    April 11, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    NQQ
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE EVENT WAS NOT DEVICE RELATED BUT OCCURRED DUE TO THE AIR NOT BEING FULLY PURGED FROM THE CATHETER PRIOR TO USE, AS INSTRUCTED IN THE IFU. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED ALL MFG PROCESSES WERE COMPLETED AND THE DEVICE WAS MFG IN ACCORDANCE WITH SJM SPECS.

    Description of Event or Problem · 1

    THE DRAGONFLY CATHETER WAS NOT PURGED PROPERLY SO WHEN PURGED IN THE RCA PRIOR TO OCT IMAGING THE CAPTURED AIR WAS INTRODUCED INTO THE ARTERY. THE PT EXPERIENCED CHEST PAIN AND MEDICATIONS WERE ADMINISTERED. THE PT WAS STABLE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGONFLY IMAGING CATHETER INTERVASCULAR IMAGING CATHETER NQQ ST JUDE MEDICAL 13751-02 DF-11-751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention