BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 2881568 · Received December 18, 2012

    Report

    Report Number
    3008493244-2012-00039
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K121521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION, SUCH AS PATIENT INFORMATION, WERE UNANSWERED BY THE FACILITY, DUE TO A TURNOVER IN STAFF. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. DISSECTION IS A KNOWN POSSIBLE ADVERSE EFFECT 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

    THE PHYSICIAN WAS IN TRAINING AND PERFORMING HIS 3RD CASE WITH THE DEVICE. HE ATTEMPTED TO ADVANCE THE 0.035" LATCHWIRE WITHOUT SUCCESS. A SECOND PHYSICIAN TOOK OVER AND AN ANGIOGRAM PERFORMED REVEALED A DISSECTION. THE PHYSICIAN INSERTED A DILATOR FOLLOWED BY A GUIDEWIRE AND WAS ABLE TO TRAVERSE WITH GUIDEWIRE AND PERFORM A LONG-BALLOON ANGIOPLASTY, WHICH RESOLVED THE DISSECTION. THE PATIENT RECOVERED WITH NO FURTHER SEQUELAE AND WAS DISCHARGED THE FOLLOWING DAY.

    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 UNK Hospitalization| R