BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3060044 · Received April 11, 2013

    Report

    Report Number
    3008493244-2013-00019
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K121521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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, 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 PHYSICIAN INDICATED THAT PATIENT FACTORS AND/OR AMBULATION OF THE PATIENT CONTRIBUTED TO THE REPORTED HEMATOMA.

    Description of Event or Problem · 1

    THIS WAS A ROUTINE ACCESS PROCEDURE WITH THE AXERA DEVICE. NO PRE OR POST GROIN ANGIOGRAM WAS TAKEN. THE PATIENT'S CORONARY ANATOMY WAS DIFFUSELY DISEASED AND HIGHLY CALCIFIED. THE PHYSICIAN STENTED THE RCA. THE CASE WAS EXTREMELY DIFFICULT DUE TO THE PRESENCE OF CALCIUM THROUGHOUT. THE ARTERY WAS PERFORATED DURING A BALLOON INFLATION. ANGIOMAX WAS STOPPED POST-CATH AND THE SHEATH WAS REMOVED 2 HOURS POST PROCEDURE. HEMOSTASIS WAS DIFFICULT TO ACHIEVE. A HEMATOMA WAS NOTED AFTER HEMOSTASIS WAS THOUGHT TO HAVE BEEN ACHIEVED. PATIENT AMBULATED TWO HOURS LATER AND HEMATOMA WAS PRESENT. A FEMOSTOP WAS APPLIED. THE FOLLOWING MORNING, "LARGE" HEMATOMA WAS PRESENT AND PATIENT WAS TAKEN FOR SURGICAL INTERVENTION. THE PHYSICIAN BELIEVES THE PATIENT'S AGE, CALCIFIED FEMORAL ANATOMY (INFERRED FROM HIGH PRESENCE OF CALCIUM IN CORONARIES), AND 2 HOUR AMBULATION AFTER HEMATOMA WAS NOTED, CONTRIBUTED TO THE ADVERSE EVENT. THE PATIENT RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155284 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention STENT| BALLOON| ANGIOMAX