BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA ACCESS SYSTEM

    MDR report key: 2850686 · Received November 20, 2012

    Report

    Report Number
    3008493244-2012-00034
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K113110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU) WAS REVIEWED. PSEUDOANEURYSM AND HEMATOMA ARE KNOWN POSSIBLE ADVERSE EFFECTS OF VASCULAR ACCESS PROCEDURES AND 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, 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

    THE PATIENT TREATED WITH COUMADIN DID NOT DISCONTINUE USE PRIOR TO THE PROCEDURE. THE PHYSICIAN ADMINISTERED 1 UNIT OF PLASMA AND PROCEEDED WITH THE PERIPHERAL (ATHERECTOMY/BALLOON) CASE. ACCESS WAS OBTAINED ON THE RIGHT FOR INTERVENTION ON THE LEFT LEG. THE NURSE SATISFACTORILY ACCESSED THE CFA, BUT ENCOUNTERED DIFFICULTY INSERTING THE LAST 2" OF GUIDEWIRE. PER STANDARD PRACTICE AT THIS FACILITY, 4-6,000 UNITS OF HEPARIN WERE ADMINISTERED, FOLLOWED BY 40 MG PROTAMINE AT THE CONCLUSION OF THE PROCEDURE WITH IMMEDIATE SHEATH PULL. COMPRESSION WAS HELD FOR 20 MINUTES WITH NO SIGNS OF HEMATOMA. THE CASE WAS CONCLUDED WITHOUT INCIDENT WITH GOOD HEMOSTASIS. THE PATIENT WAS TRANSFERRED TO ANOTHER WARD AND KEPT OVERNIGHT. THE NEXT MORNING, UPON AMBULATION, THE PATIENT EXPERIENCED PAIN IN HER GROIN. A 2-3 INCH HEMATOMA WAS NOTED AND PRESSURE HELD FOR 20-30 ADDITIONAL MINUTES. ULTRASOUND REVEALED A PSEUDOANEURYSM (APPROXIMATELY 4 CM) 6 INCHES ABOVE THE ACCESS SITE, WHICH RESOLVED WITH MANUAL COMPRESSION, CONFIRMED BY ULTRASOUND. THE PATIENT RECOVERED WITH NO FURTHER SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization HEPARIN| PROTAMINE| COUMADIN| PLASMA