BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO ACE¿ ADVANCED MICRO ACCESS SYSTEM

    MDR report key: 19078213 · Received April 10, 2024

    Report

    Report Number
    3011642792-2024-00020
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 3, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    DRE
    UDI-DI
    00884450785119
    PMA / PMN Number
    K232609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INVESTIGATED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE IDENTIFIED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGES THAT DURING A PROCEDURE THE NITINOL WIRE BROKE OFF IN THE PATIENT DURING ACCESS. IT WOULD NOT COME OUT THROUGH THE INTRODUCER SO THE WIRE AND INTRODUCER NEEDED TO BE REMOVED TO START OVER. PROCEDURE GAE, ACCESSING THE POPLITEAL ARTERY ANTEGRADE ORIENTATION. THE REMAINDER OF THE WIRE LAYS IN THE SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412138 MICRO ACE¿ ADVANCED MICRO ACCESS SYSTEM MICRO ACCESS SYSTEM DRE MERIT MEDICAL SYSTEMS MEXICO I2857630 00884450785119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown