BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 3812867 · Received May 15, 2014

    Report

    Report Number
    2024168-2014-03066
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. EVENT DATE: DATE HAS BEEN ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE WAS USED BUT COULD NOT BE INSERTED INTO THE NON-ABBOTT INTRODUCER. THE GUIDE WIRE AND INTRODUCER WERE REMOVED AS A SINGLE UNIT. AFTER REMOVAL OUT OF THE PATIENT ANATOMY, IT WAS NOTED THAT THE COATING WAS SEPARATED AND MOVED FORWARD REMAINING ON THE CORE BUT CREATING A "STEP" IN THE GUIDE WIRE SHAFT. ANOTHER BMW GUIDE WIRE WAS USED TO SUCCESSFULLY CONCLUDE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290741 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1