BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3122021 · Received May 16, 2013

    Report

    Report Number
    3008493244-2013-00020
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K123135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NOT POSSIBLE. THE LOT NUMBER WAS NOT REPORTED AND COULD NOT BE DISTINGUISHED FROM MULTIPLE LOTS SHIPPED TO THE FACILITY. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT WAS NOT PERFORMED. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNINGS AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. THE CLINICAL DESCRIPTION SUGGESTS THAT THE DEVICE WAS NOT CORRECTLY POSITIONED WITHIN THE ARTERY WHEN THE HEEL WAS DEPLOYED. BASED ON THE REVIEW COMPLETED, IT IS UNKNOWN WHETHER OR NOT THE DEVICE WAS OUT OF SPECIFICATION AS IT CANNOT BE DEFINITIVELY DETERMINED. THE ROOT CAUSE, SUGGESTS USER ERROR HOWEVER BASED ON AVAILABLE INFORMATION CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT WAS OF NORMAL SIZE AND SEVERE CALCIFICATION OF THE ARTERY WAS OBSERVED, BUT NO TORTUOSITY. THE PROCEDURE PROCEEDED AS PLANNED UNTIL THE OPERATOR ATTEMPTED TO POSITION THE DEVICE AGAINST THE ARTERIAL WALL AT WHICH TIME THE DEVICE PULLED OUT OF THE PATIENT. IT IS UNKNOWN WHETHER THE HEEL WAS DEPLOYED IN THE ARTERY OR OUTSIDE OF THE ARTERY IN THE SUBCUTANEOUS TISSUE. MANUAL COMPRESSION WAS HELD TO OBTAIN HEMOSTASIS AND NO COMPLICATIONS OCCURRED. THE PHYSICIAN ENDED UP ACCESSING THE OTHER SIDE AND USED AN ANGIOSEAL. THE PATIENT RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217033 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention