BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY IMAGING CATHETER

    MDR report key: 2508840 · Received March 27, 2012

    Report

    Report Number
    3004672267-2012-00002
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 22, 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

    BASED ON THE INFO PROVIDED INCIDENT WAS NOT CAUSED BY THE DRAGONFLY IMAGING CATHETER USED FOR OCT IMAGING. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE.

    Description of Event or Problem · 1

    IN PREPARATION FOR A CASE WITH OCT IMAGING OF A STENT IN THE MID LAD, A DISSECTION OF THE VERY SHORT LEFT-MAIN WAS CAUSED BY THE GUIDING CATHETER. THIS WAS NOT APPARENT UNTIL AFTER OCT IMAGING. VERY POOR BLOOD CLEARANCE WAS OBTAINED SUCH THAT THE PHYSICIAN ASSUMED THAT THE GUIDING CATHETER HAD SLIPPED OUT PRIOR TO THE PULLBACK. AFTER THE PULLBACK, THE PT WENT INTO VENTRICULAR FIBRILLATION AND A LARGE DISSECTION EXTENDING ALONG THE LAD AND POSSIBLY BACK TO THE AORTA. PT WAS STABILIZED AND LEFT-MAIN AND LAD WERE SUCCESSFULLY TREATED WITH A NEW PROXIMAL STENT. PHYSICIAN STATED THAT ABSOLUTELY THERE WAS NO SUGGESTION THAT THE IMAGING CATHETER CAUSED THIS INCIDENT AND HE HAD A SIMILAR EXPERIENCE RECENTLY (IN A NON OCT IMAGING CASE).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R