BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOAVF® ACCESS KIT

    MDR report key: 13538920 · Received February 15, 2022

    Report

    Report Number
    1721504-2022-00018
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 10, 2022
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    OEX
    UDI-DI
    00884450412084
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WILL NOT BE RETURNING FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING A FISTULA PROCEDURE THE CLINICIAN WAS ATTEMPTING TO USE THE ELLIPSYS DEVICE DURING FISTULA PROCEDURE. IT WAS ALLEGED THERE WAS NO VESSEL TORTUOSITY, THE ARTERY DIAMETER WAS 2.5MM AND VEIN DIAMETER WAS 3MM. THE DISTANCE BETWEEN ARTERY AND VEIN WAS NOT GREATER THAN 1.5MM. IFU WAS FOLLOWED. IT IS ALLEGED THAT DURING THE PROCEDURE WHILE THE CATHETER WAS BEING PULLED BACK ACROSS THE ANASTOMOSIS, IT DID NOT CATCH ON THE ARTERIAL WALL AND WAS RETRACTED INTO THE VEIN AT WHICH POINT IT BECAME STUCK. NEITHER THE CATHETER NOR THE SHEATH WOULD ADVANCE OR RETRACT. THE CATHETER WAS ROTATED AND AT ONE POINT CLOSED TO TRY AND HELP ADVANCE OR RETRACT, BUT WAS UNSUCCESSFUL. THE CLINICIAN USED FORCE TO REMOVE THE CATHETER AND SHEATH TOGETHER WHILE MAINTAINING WIRE ACCESS. IT IS BELIEVED THE CATHETER MAY HAVE BECOME STUCK ON A VALVE IN THE PERFORATING VEIN. THE ACCOUNT ALLEGES THAT THE DEVICE WAS STUCK AROUND THE OUTSIDE OF THE SHEATH AND BOTH HAD TO BE REMOVED TOGETHER. A SMALL HEMATOMA FORMED AND A SLIGHTLY LARGER EXIT HOLE WAS CREATED IN THE ANTERIOR VEIN WALL. THIS WAS RESOLVED WITH PROLONGED PRESSURE HOLD AND A SUTURE AT THE SKIN ENTRY POINT. A NEW CATHETER AND SHEATH WERE INSERTED OVER THE ORIGINAL WIRE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17028 ENDOAVF® ACCESS KIT CADRIOVASCULAR CATHETER SHEATH INTRODUCER KIT OEX MERIT MEDICAL SYSTEMS INC. H2119871 00884450412084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention