BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3020585 · Received March 21, 2013

    Report

    Report Number
    3008493244-2013-00012
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 20, 2013
    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. AN ANGIOGRAM OF THE GROIN 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. 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 ANALYSIS COMPLETED, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPECIFICATION. THE ROOT CAUSE, BASED ON AVAILABLE INFO, IS UNK AS IT CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    THIS WAS A DIAGNOSTIC CASE. THE PT WAS NOT OBESE. MILD CALCIFICATION, BUT NO TORTUOSITY OR SCARRING WAS OBSERVED. THE INITIAL ACCESS PUNCTURE WAS SATISFACTORY. THE AXERA DEVICE WAS SUCCESSFULLY DEPLOYED. AN ANGIOGRAM OF THE GROIN REVEALED SOME LEAKAGE AROUND THE SHEATH, WHICH THE PHYSICIAN BELIEVES WAS THE PILOT HOLE LEAKING. PRESSURE WAS HELD FOR 5 MINUTES TO STOP THE LEAKAGE AT WHICH POINT IT SUBSIDED. THE PHYSICIAN CHOSE NOT TO ADMINISTER ANTICOAGULANTS AND POSTPONED THE INTERVENTION TO ANOTHER DAY. HEMOSTASIS WAS ACHIEVED IN 10 MINUTES AND THE PT RECOVERED WITH NO FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117302 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 12L03215

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization EFFIENT, 10MG| ASPIRIN, 325 MG