BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2911528 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00251
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. DATE OF EVENT AND IMPLANT DATE - ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT INTERNAL CAROTID ARTERY. THE XACT WAS ADVANCED TO THE LESION THROUGH A NON-ABBOTT SHEATH AND WHEN INJECTING CONTRAST, BEFORE DEPLOYMENT, THERE WAS AIR OBSERVED COMING BACK INTO THE INJECTION DEVICE. THE XACT WAS SUCCESSFULLY DEPLOYED. IT IS UNKNOWN IF IT IS THE XACT OR THE SHUTTLE CATHETER THAT IS LEAKING. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17142 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 6F SHUTTLE