BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOAVF ACCESS KIT

    MDR report key: 12397087 · Received August 31, 2021

    Report

    Report Number
    1721504-2021-00063
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    June 11, 2021
    Report Date
    August 26, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OEX
    UDI-DI
    10884450412081
    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 REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT SIGNIFICANT EXTRAVASATION OF BLOOD FLOW OCCURRED DURING USE OF AN ELLIPSYS CATHETER FOR PATIENT TREATMENT. IT WAS REPORTED THAT THE NEEDLE CAME OUT OF THE PERFORATOR VEIN BEFORE PUNCTURING THE RADIAL ARTERY. THE PATIENT REQUIRED AN OPEN INCISION TO REPAIR THE BLOOD FLOW OUTSIDE OF THE VESSEL AND HAD A SURGICAL BRACHIOBASILIC AVF SUCCESSFULLY CREATED. THE PATIENT REQUIRED OBSERVATION OVERNIGHT. ONCE THE PATIENT WAS STABLE, THE PATIENT WAS RELEASED HOME. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300057 ENDOAVF ACCESS KIT CADRIOVASCULAR CATHETER SHEATH INTRODUCER KIT OEX MERIT MEDICAL SYSTEMS INC. 10884450412081 10884450412081

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R