BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAILBLAZER SUPPORT CATHETER

    MDR report key: 8969195 · Received September 6, 2019

    Report

    Report Number
    2183870-2019-00434
    Event Type
    Injury
    Date Received
    September 6, 2019
    Report Date
    November 20, 2019
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K092299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 SUPPORT CATHETERS (BOTH ANGLED AND NOT ANGLED). SURVEY RESULTS RECEIVED FOR A CARDIOTHORACIC SURGEON PRACTICING IN ITALY WHO WITHIN THE LAST 12 MONTHS USED A TRAILBLAZER NOT ANGLED CATHETER IN 250 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. SURVEY RESULTS RECEIVED FOR A CARDIOTHORACIC SURGEON PRACTICING IN ITALY WHO WITHIN THE LAST 12 MONTHS USED A TRAILBLAZER ANGLED CATHETER IN 150 PROCEDURES, AND A TRAILBLAZER NOT ANGLED CATHETER IN 250 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. THE FOLLOWING ADVERSE EVENTS/COMPLICATIONS WERE REPORTED DURING USE OF THE TRAILBLAZER ANGLED SUPPORT CATHETER: ACCESS SITE COMPLICATIONS (15 OCCURRENCES, NONE OF WHICH WERE RELATED TO THE DEVICE ITSELF), LOCAL OR SYSTEMIC INFECTION INCLUDING SEPSIS (8 OCCURRENCES, NONE OF WHICH WERE RELATED TO THE DEVICE ITSELF), PERFORATION AND VESSEL RUPTURE (6 OCCURRENCES, 2 OF WHICH WERE RELATED TO THE DEVICE ITSELF), AND SURGICAL INTERVENTION (5 OCCURRENCES, NONE OF WHICH WERE RELATED TO THE DEVICE ITSELF). FOR EACH OF THE COMPLICATIONS REPORTED, ALL WERE DESCRIBED AS BEING NOT AT ALL CONCERNING, WITH THE EXCEPTION OF THE PERFORATION AND VESSEL RUPTURE EVENTS WHICH WERE DESCRIBED AS SOMEWHAT CONCERNING. FOR THE PERFORATION AND VESSEL RUPTURE EVENTS, THE DEVICES WERE USED IN HARD-TO-REACH COMPLEX ANATOMIES AND THE OPERATOR WAS AWARE THAT THIS WAS A POTENTIAL COMPLICATION AS DESCRIBED IN THE IFU. THE FOLLOWING ADVERSE EVENTS/COMPLICATIONS WERE REPORTED DURING USE OF THE TRAILBLAZER NOT ANGLED SUPPORT CATHETER: ARTERIAL DISSECTION (11 OCCURRENCES, 2 WHICH WERE RELATED TO THE DEVICE ITSELF), ARTERIAL SPASM (20 OCCURRENCES, NONE OF WHICH WERE RELATED TO THE DEVICE ITSELF), ARTERIAL THROMBOSIS (3 OCCURRENCES, NONE OF WHICH WERE RELATED TO THE DEVICE ITSELF), PERFORATION AND VESSEL RUPTURE (5 OCCURRENCES, NONE OF WHICH WERE RELATED TO THE DEVICE ITSELF), AND SURGICAL INTERVENTION (12 OCCURRENCES, NONE OF WHICH WERE RELATED TO THE DEVICE ITSELF). FOR EACH OF THE COMPLICATIONS REPORTED, THE ARTERIAL DISSECTION (EXPECTED COMPLICATION DUE TO CHRONIC OCCLUSIONS) AND ARTERIAL SPASM EVENTS WERE REPORTED TO BE NOT AT ALL CONCERNING; THE PERFORATION AND VESSEL RUPTURE EVENTS, AND SURGICAL INTERVENTION EVENTS WERE REPORTED AS BEING SOMEWHAT CONCERNING; AND THE ARTERIAL THROMBOSIS EVENT (ACUTE LIMB ISCHEMIA DUE TO DISTAL EMBOLIZATION) WAS REPORTED AS BEING VERY CONCERNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764031 TRAILBLAZER SUPPORT CATHETER CATHETER, PERCUTANEOUS DQY COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention