BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY

    MDR report key: 9968651 · Received April 16, 2020

    Report

    Report Number
    3009600098-2020-00008
    Event Type
    Injury
    Date Received
    April 16, 2020
    Report Date
    April 30, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    ORD
    PMA / PMN Number
    K093857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE RISKS OF VENTRICULAR FIBRILLATION (VFIB) ASSOCIATED WITH FREQUENCY-DOMAIN OPTICAL COHERENCE TOMOGRAPHY (OCT)/OPTICAL FREQUENCY DOMAIN IMAGING (OFDI) REMAIN UNDETERMINED. THE OCCURRENCE OF VFIB DURING OCT/OFDI FOR UNSELECTED INDICATIONS WAS RETROSPECTIVELY STUDIED AND THE FREQUENCY OF VFIB AND PATIENT AND PROCEDURAL CHARACTERISTICS WERE INVESTIGATED. A TOTAL OF 4,467 OCT/OFDI PULLBACK EXAMINATIONS WERE PERFORMED IN 1,754 PATIENTS. IN CASES WHERE OCT WAS USED, VFIB OCCURRED IN 23 OF 1,651 PATIENTS. (DOI:10.1252/CIRCJ.CJ-19-0736)

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN CIRCULATION JOURNAL : OFFICIAL JOURNAL OF THE JAPANESE CIRCULATION SOCIETY TITLED "VENTRICULAR FIBRILLATION DURING OPTICAL COHERENCE TOMOGRAPHY/OPTICAL FREQUENCY DOMAIN IMAGING - A LARGE SINGLE-CENTER EXPERIENCE" BY TERADA, NORIKO ET AL.: A TOTAL OF 31 CASES OF VFIB OCCURRED IN 30 PATIENTS (PER PATIENT, 30/1,754 [1.7%]; PER PULLBACK, 31/4,467 [0.69%]). THE INCIDENCE OF VFIB PER PATIENT WAS 1.6% (14/855) DURING DIAGNOSTIC CATHETERIZATION, 2.2% (12/538) DURING ELECTIVE PCI, AND 1.1% (4/361) DURING PRIMARY OR EMERGENCY PCI (P=0.466). (DOI:10.1252/CIRCJ.CJ-19-0736).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433822 DRAGONFLY OPTICAL COHERENCE TOMOGRAPHY, INTRAVASCULAR CATHETER ORD ST. JUDE MEDICAL CATD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other