BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOAVF ACCESS KIT

    MDR report key: 12050064 · Received June 23, 2021

    Report

    Report Number
    1721504-2021-00044
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 11, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OEX
    UDI-DI
    00884450412084
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A LOT NUMBER WAS REPORTED, AND A REVIEW OF THE MANUFACTURING HISTORY RECORD IS IN PROGRESS.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING VASCULAR ACCESS ATTEMPT ON A PATIENT DIAGNOSED WITH CORONARY ARTERY DISEASE [CAD], THE PATIENT SUFFERED A VASOVAGAL EFFECT AND CODED AS THE PHYSICIAN STUCK THE PATIENT WITH THE ACCESS NEEDLE. A CODE WAS CALLED BY THE MEDICAL STAFF AND HOSPITAL PROTOCOLS WERE INITIATED. THE PATIENT RECOVERED AND IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943946 ENDOAVF ACCESS KIT ACCESS KIT OEX MERIT MEDICAL SYSTEMS INC. H1817969 00884450412084

    Patients

    Seq Age Sex Outcome Treatment
    1