BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 2885120 · Received December 19, 2012

    Report

    Report Number
    3008493244-2012-00041
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K121521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NOT POSSIBLE. HOWEVER, A PHOTO RECEIVED CONFIRMED THE DESCRIPTION OF THE EVENT. 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. VASCULAR HEMORRHAGE 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 UNK WHETHER OR NOT THE DEVICE WAS OUT OF SPECIFICATION AS IT CANNOT BE DEFINITIVELY DETERMINED. THE PROBABLE ROOT CAUSE, BASED ON AVAILABLE INFO, IS THE REPORTED HIGH STICK, WHICH AFFECTS THE COMPRESSIBILITY OF THE ACCESS SITE OVER THE FEMORAL HEAD.

    Description of Event or Problem · 1

    THIS WAS A PERIPHERAL INTERVENTIONAL PROCEDURE FOR A BELOW-THE-KNEE OCCLUSION. THE AXERA CASE WAS UNEVENTFUL, HOWEVER THE INITIAL ACCESS PUNCTURE WAS HIGH. THE PROCEDURE WAS UNEVENTFUL AND THE PT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2012, THE PT WAS SEEN FOR FOLLOW-UP AND COMPLAINED OF FLANK PAIN (VERY TENDER IN THE AREA). CT CONFIRMED A LARGE RETROPERITONEAL HEMATOMA (RPH). HOWEVER, ANGIO REVEALED IT WAS NOT ACTIVELY BLEEDING AT THE TIME. THE PT WAS GIVEN 4 UNITS OF BLOOD, WHICH RESOLVED THE RPH. THE PT RECOVERED WITH NO FURTHER SEQUELAE AND WAS DISCHARGED ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R ISOVUE| HEPARIN| NITROGLYCERIN| OMNI FLUSH| EVERCROSS| NANOCROSS| MINI TREK| TURBOHAWK SS-C| SPIDERFX| REOPRO BOLUS| ARMADA