BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3240396 · Received July 18, 2013

    Report

    Report Number
    3008493244-2013-00032
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K123135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND FAILURE ANALYSIS PERFORMED. EXAMINATION OF THE DEVICE CONFIRMED THAT THE HEEL WAS FUNCTIONING PROPERLY. 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 APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNINGS AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. THE CLINICAL DESCRIPTION SUGGESTS THAT THE HEEL WAS FUNCTIONING (DEPLOYING AND RELEASING) PROPERLY AS VERIFIED BY THE TECH FOLLOWING THE CASE. 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.

    Description of Event or Problem · 1

    THIS WAS PERIPHERAL ANGIOGRAPHY VIA THE RIGHT FEMORAL ARTERY, CONVERTED TO INTERVENTION. CALCIFICATION, DISEASE, AND SOME TORTUOSITY WAS NOTED. THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. WHILE PULLING THE DEVICE BACK TO TENT THE ARTERY, THE DEVICE PULLED OUT OF THE TISSUE TRACT. THE PHYSICIAN CONVERTED TO STANDARD ACCESS VIA A 5F SHEATH. THE CASE PROCEEDED WITHOUT ANY BLEEDING OR HEMATOMA AROUND THE SHEATH. THE 5F SHEATH WAS LATER EXCHANGED FOR A 7F LONG SHEATH. LATER, THE SCRUB TECHNICIAN RETRIEVED THE DEVICE AND VERIFIED FUNCTIONALITY OF THE HEEL BY RELEASING AND DEPLOYING THE HEEL. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 AND RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334216 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 13D01030

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization 6,500 UNITS HEPARIN PLUS ADDITIONAL 2,500 UNITS