BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYTEM

    MDR report key: 4112891 · Received September 17, 2014

    Report

    Report Number
    3008493244-2014-00027
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K140201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT TO OBTAIN ADDITIONAL COMPLAINT INFORMATION FROM THE USER FACILITY, SUCH AS A PATIENT INFORMATION AND EVENT DATE, WAS MADE WITHOUT SUCCESS. 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. HEMATOMA AND OTHER POSSIBLE ADVERSE EFFECTS OF VASCULAR ACCESS PROCEDURES ARE LISTED IN THE ADVERSE EFFECTS SECTION OF THE PRODUCT IFU. THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNINGS AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. 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, BASED ON AVAILABLE INFORMATION, IS UNKNOWN AS IT CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    MULTIPLE ATTEMPTS WERE MADE TO GAIN ACCESS TO THE ARTERY, WHICH WAS IN A CALCIFIED SECTION OF THE SFA. AS A RESULT OF (B)(6) BLEEDING AROUND THE AXERA UPON INSERTION, THE PHYSICIAN PROCEEDED TO CONVERT THE CASE TO STAND ARTERIOTOMY. HE SLID THE HEEL ACTUATOR FORWARD, BUT HAD DIFFICULTY DISENGAGING THE HEEL AND DECIDED TO SEVER THE HEEL DEPLOYMENT WIRE. HE WAS THEN ABLE TO REMOVE THE DEVICE FROM THE PATIENT AND MANUALLY SEPARATE THE DEVICE BODY FROM THE LATCHWIRE. A 6F SHEATH WAS INSERTED OVER THE LATCHWIRE. HOWEVER, BLOOD CONTINUED TO LEAK AROUND THE SHEATH AND A HEMATOMA WAS NOTED. THE PHYSICIAN UPSIZED TO A 7F SHEATH AND HEMOSTASIS WAS ACHIEVED, HOWEVER, BLOOD FLOW IN THE SFA WAS THEN IMPAIRED. THE SHEATH WAS REMOVED THE MANUAL COMPRESSION HELD. ACCESS WAS GAINED IN THE LEFT COMMON FEMORAL AND AN UP AND OVER APPROACH WAS MADE TO VISUALIZE THE PREVIOUS ARTERIOTOMY. AS THE CALCIFICATION WAS IMPEDING MANUAL COMPRESSION AND HEMOSTASIS, A BALLOON WAS USED TO FACILITATE HAEMOSTASIS, BUT WAS UNSUCCESSFUL. A COVERED STENT WAS THEN SUCCESSFULLY USED TO SEAL THE ARTERIOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577103 AXERA 2 ACCESS SYTEM INTRODUCER CATHETER DYB ARSTASIS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLOON| 6F/7F SHEATH| STENT