BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH 1 GUIDE CATHETER

    MDR report key: 589161 · Received March 30, 2005

    Report

    Report Number
    6000093-2005-00298
    Event Type
    Malfunction
    Date Received
    March 30, 2005
    Date of Event
    February 16, 2005
    Report Date
    February 28, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DYB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURER REPORT NUMBER 6000130-2005-00291. DURING A PTA TREATMENT PROCEDURE, THE DISTAL END OF THE MARCH 1 GUIDE CATHETER BECAME STUCK ON THE V18 GUIDE WIRE. THE PATIENT WAS ASYMPTOMATIC DURING THIS EVENT. THE LESION BEING TREATED WAS A CALCIFIED, 90% STENOTIC LESION IN THE LEFT ILIAC ARTERY. THE PHYSICIAN USED A 7 FR J-SHEATH FOR VASCULAR ACCESS. IT WAS NOTED THAT RESISTANCE WAS MET WITH INSERTION OF THE MARCH1 GUIDE CATHETER. THE MARCH1 GUIDE CATHETER WAS REMOVED WIHT THE V18 GUIDE WIRE, AND REPLACED WITH ANOTHER GUIDE CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH 1 GUIDE CATHETER GUIDE CATHETER DYB BOSTON SCIENTIFIC NA 6464355

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN