BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3180260 · Received June 13, 2013

    Report

    Report Number
    3008493244-2013-00028
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K123135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND FAILURE ANALYSIS PERFORMED. EXAMINATION OF THE DEVICE CONFIRMED THE NARRATIVE OF THE COMPLAINT AND THE LATCHWIRE WAS OBSERVED TO BE KINKED. THE LATCHING COMPONENT WAS DAMAGED, SPECIFICALLY, THE TAB WAS PARTIALLY STRAIGHTENED. THERE WERE NO CRACKS OR STRESS MARKS ON THE TAB AND THE LATCH ITSELF WAS UNDAMAGED. 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. THE IFU PROVIDES THE FOLLOWING PRECAUTION, "AVOID EXCESSIVE ROTATION, BENDING OR KINKING OF THE AXERA ACCESS DEVICE DURING INSERTION AND REMOVAL AS THIS MAY CAUSE DAMAGE OR AFFECT THE PERFORMANCE OF THE DEVICE INCLUDING OBSTRUCTION OF THE NEEDLE LUMEN. NO UPDATE OF THE IFU IS REQUIRED. BASED ON THE ANALYSIS COMPLETED TO DATE, THE LATCHWIRE APPEARS TO HAVE SEPARATED FROM THE DEVICE BECAUSE THE TAB MAY HAVE BEEN DAMAGED (STRAIGHTENED) DURING USE. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN OPENED TO CONTINUE THE INVESTIGATION INTO THIS EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS STILL IN TRAINING WITH THE AXERA DEVICE AND THIS WAS THE 7TH CASE UNDER THE SUPERVISION OF AN ARSTASIS REPRESENTATIVE. THIS WAS A CEREBRAL ANGIOGRAM. THE PATIENT WAS OBESE. NO SCARRING WAS NOTED; THE INSERTION SITE WAS CALCIFIED, BUT NOT EXCESSIVELY TORTUOUS. THE PHYSICIAN WAS ATTEMPTING TO INSERT THE DEVICE THROUGH THE SKIN AND INTO THE LUMEN OF THE VESSEL. THE DEVICE WAS NOT PENETRATING THE SKIN AND/OR CALCIFIED VESSEL. HE EXPERIENCED QUITE A BIT OF DIFFICULTY GETTING A WIRE UP THE FEMORAL AND ILIAC ARTERIES. THE PROXIMAL PART OF THE WIRE BECAME KINKED. WITH A GOOD DEAL OF TORQUE AND MANIPULATION OF THE DEVICE, THE PHYSICIAN CONTINUED TO TRY TO ADVANCE THE LATCHWIRE INTO THE HEAVILY DISEASED ARTERY WITHOUT SUCCESS, AT WHICH POINT THE PHYSICIAN DECIDED TO BAIL OUT OF THE PROCEDURE. AS THE DOCTOR PULLED BACK THE DEVICE THE SECOND TIME, HE REALIZED THE LATCHWIRE WAS NOT ATTACHED, BUT PRESENTED OUTSIDE THE BODY AND HE WAS ABLE TO SECURE IT MANUALLY. HE PLACED A SHEATH OVER THE LATCHWIRE AND CONTINUED WITH THE PROCEDURE. THE PATIENT RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269237 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 12L13219

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR