BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTERITY TRA

    MDR report key: 9749291 · Received February 25, 2020

    Report

    Report Number
    1220452-2020-00025
    Event Type
    Injury
    Date Received
    February 25, 2020
    Report Date
    February 25, 2020
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQO
    PMA / PMN Number
    K161287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY WAS CONDUCTED ON BEHALF OF MEDTRONIC TO SEEK OUT POTENTIAL NEW RISKS AND ASSESS PERFORMANCE OF THE DXTERITY DIAGNOSTIC CATHETER. SURVEY RESULTS WERE OBTAINED FROM AN INTERVENTIONAL CARDIOLOGIST IN PRACTICE 18 YEARS. IN THE PAST 12 MONTHS THE PHYSICIAN PERFORMED 180 PROCEDURES USING THE DXTERITY DIAGNOSTIC CATHETER. 25 PROCEDURES USING THE 5 FR X100CM, 130 PROCEDURES USING THE INTERMEDIATE SIZES, AND 25 PROCEDURES USING THE 6F X 125CM. THE FOLLOWING COMPLICATIONS ADVERSE EVENTS/EFFECTS WERE ENCOUNTERED WHEN USING THE DXTERITY DIAGNOSTIC CATHETER PRODUCT OVER THE LAST 12 MONTHS. 1 PLAQUE DISLODGEMENT EVENT OCCURRED WHICH WAS RELATED TO THE PROCEDURE BUT NOT DIRECTLY TO THE MEDTRONIC DXTERITY DIAGNOSTIC CATHETER 3 VASOSPASM EVENTS OCCURRED WHICH WERE RELATED TO THE PROCEDURE BUT NOT DIRECTLY TO THE MEDTRONIC DXTERITY DIAGNOSTIC CATHETER. IN ONE CASE THE DXTERITY DIAGNOSTIC CATHETER DID NOT PERFORM AS EXPECTED WHEN DELIVERING GUIDEWIRES TO SELECTED SITES IN THE CORONARY AND VASCULAR SYSTEM. THIS WAS ATTRIBUTED TO A VERY KINKED SUBCLAVIAN ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212731 DXTERITY TRA CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other