BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAILBLAZER SUPPORT CATHETER

    MDR report key: 8968810 · Received September 6, 2019

    Report

    Report Number
    2183870-2019-00430
    Event Type
    Injury
    Date Received
    September 6, 2019
    Report Date
    September 6, 2019
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K092299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC CONDUCTED A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY TO SEEK OUT POTENTIAL NEW RISKS AND ASSESS PERFORMANCE OF THE TRAILBLAZER NOT ANGLED SUPPORT CATHETER. SURVEY RESULTS RECEIVED FOR AN INTERVENTIONAL CARDIOLOGIST PRACTICING IN GERMANY WHO WITHIN THE LAST 12 MONTHS USED A TRAILBLAZER (NOT ANGLED) CATHETER IN 30 PROCEDURES TO GUIDE AND SUPPORT A GUIDEWIRE DURING ACCESS OF THE VASCULATURE, TO ALLOW FOR WIRE EXCHANGES, AND/OR TO PROVIDE A CONDUIT FOR THE DELIVERY OF SALINE SOLUTIONS OR DIAGNOSTIC CONTRAST AGENTS. DURING USE OF THE TRAILBLAZER DEVICE THE FOLLOWING ADVERSE EVENTS/COMPLICATION WAS REPORTED: PERFORATION AND VESSEL RUPTURE (2 OCCURRENCES, 1 OF WHICH WERE RELATED TO THE DEVICE ITSELF). THIS PERFORATION COMPLICATION WAS REPORTED TO BE SOMEWHAT CONCERNING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764351 TRAILBLAZER SUPPORT CATHETER CATHETER, PERCUTANEOUS DQY COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1