BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 2921728 · Received January 15, 2013

    Report

    Report Number
    3008493244-2013-00002
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K121521
    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. PHOTOS 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. DISSECTION 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 ROOT CAUSE, BASED ON AVAILABLE INFORMATION, IS UNKNOWN AS IT CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    THIS WAS A DIAGNOSTIC CASE, WHICH CONVERTED TO A PERCUTANEOUS CORONARY INTERVENTION WITH STENT PLACEMENT. NO CALCIFICATION OR SCARRING WAS OBSERVED. THE PHYSICIAN DID NOT HAVE DIFFICULTY INSERTING THE AXERA DEVICE. FOLLOWING SHEATH INSERTION, ANGIOGRAPHY REVEALED A DISSECTION AT THE INSERTION SITE. UPON DISCHARGE ON (B)(6) 2012, THE PATIENT HAD DIMINISHED PULSES IN BOTH FEET. THE PATIENT COMPLAINED OF GROIN PAIN, BECAME SYMPTOMATIC, AND WAS BROUGHT BACK FOR INTERVENTION ON (B)(6) 2012. RE-ACCESS VIA THE LEFT GROIN AND REPEATED LONG, LOW-PRESSURE BALLOON INFLATIONS WERE PERFORMED. THE PATIENT RECOVERED WITH NO FURTHER SEQUELAE AND WAS DISCHARGED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22110 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention