BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3233983 · Received July 16, 2013

    Report

    Report Number
    3008493244-2013-00031
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K123135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NOT POSSIBLE. 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. PSEUDOANEURYSM IS A KNOWN POSSIBLE ADVERSE EFFECT OF VASCULAR ACCESS PROCEDURES AND IS LISTED IN THE ADVERSE EFFECTS SECTION OF THE PRODUCT IFU. ADDITIONALLY, PER THE PRECAUTIONS AND DEPLOYING THE AXERA ACCESS DEVICE SECTIONS OF THE IFU, "AVOID EXCESSIVE TWISTING OR ROTATION OF THE AXERA ACCESS DEVICE DURING INSERTION, AS THIS MAY CAUSE DEVICE DAMAGE OR AFFECT DEVICE PERFORMANCE." THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNINGS AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. BASED ON THE ANALYSIS COMPLETED, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPECIFICATION. THE ROOT CAUSE, BASED ON AVAILABLE INFORMATION, IS UNKNOWN AS IT CANNOT BE DEFINITIVELY DETERMINED. THE PHYSICIAN HAS BEEN RE-TRAINED NOT TO EXERT EXCESSIVE FORCE OR TORQUING OF THE DEVICE DURING INSERTION.

    Description of Event or Problem · 1

    THIS WAS AN INTERVENTIONAL CASE ((B)(6) 2013). THE PATIENT WAS MORBIDLY OBESE AND HAD TOUGH MUSCLE TISSUE. NO CALCIFICATION, TORTUOSITY, OR SCARRING WAS NOTED. THE INITIAL ACCESS PUNCTURE WAS SATISFACTORY. TO ASSIST WITH INSERTION, THE PHYSICIAN TORQUED THE DEVICE. AN X-RAY REVEALED THE LATCHWIRE WAS BUCKLED WHERE IT IS LATCHED TO THE BODY OF THE DEVICE. THE LATCHWIRE WAS REMOVED USING FORCEPS AND THE CASE WAS CONVERTED TO STANDARD ACCESS VIA A 6F CORDIS SHEATH. TWO DAYS LATER, THE PATIENT PRESENTED WITH A PSEUDOANEURYSM (2.7 X 2.5 X 1.4 CM), WHICH WAS CONFIRMED VIAL ULTRASOUND AND RESOLVED VIA THROMBIN INJECTION. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 AND RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329101 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 13D10034

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 6F CORDIS SHEATH