BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 2903503 · Received January 3, 2013

    Report

    Report Number
    3008493244-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K121521
    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. A VIDEO AND PHOTO RECEIVED CONFIRMED THE DESCRIPTION OF THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS LOT AND NO NONCONFORMING MATERIAL REPORTS HAVE BEEN INITIATED THAT ARE RELATED TO THIS FAILURE MODE. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. DISSECTION IS A KNOWN POSSIBLE ADVERSE EFFECT OF VASCULAR ACCESS PROCEDURES AND IS LISTED IN THE ADVERSE EFFECTS SECTION OF THE PRODUCT IFU. THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNING AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. BASED ON THE REVIEW COMPLETED, THERE IS NO INDICATION THE DEVICE WAS OUT OF SPECIFICATION NOR THAT IT CAUSED THE REPORTED EVENT. THE PROBABLE ROOT CAUSED, BASED ON AVAILABLE INFO, IS INSERTION OF THE 0.038" WIRE THAT IS NOT PROVIDED BY ARSTASIS.

    Description of Event or Problem · 1

    THIS WAS A DIAGNOSTIC CASE. THE AXERA PROCEDURE WAS UNEVENTFUL. THE PHYSICIAN INSERTED A SHEATH (NOT ARSTASIS) AND ATTEMPTED TO INSERT A STANDARD 0.038" J WIRE (NOT ARSTASIS). THE WIRE APPEARED TO BE SUBINTIMAL. THE PHYSICIAN CONTINUED TO TRY AND ADVANCE THE WIRE WITHOUT SUCCESS. THE PHYSICIAN SWITCHED TO AN ANGLED GLIDEWIRE, BUT THE WIRE WAS STILL IN SUBINTIMAL PLANE ALL THE WAY UP TO THE AORTIC BIFURCATION. THE HEALTH WAS LEFT IN PIECE AND RE-ACCESS OBTAINED (WITHOUT AXERA) NEXT TO THE ORIGINAL ACCESS SITE. POST PICTURES OF GROIN SHOWED CHANGES TO COMMON FEMORAL ARTERY, BUT NO DISSECTION FLAP OR PSEUDOANEURYSM. THE DISSECTION RESOLVED ON ITS OWN. THE PHYSICIAN BELIEVED THAT THE 0.038" WIRE CAUSED THE SMALL DISSECTION AT THE PROXIMAL TIP OF SHEATH. THE PT RECOVERED WITH NO FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3665 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 12H30146

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization GLIDEWIRE