BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 1155762 · Received September 3, 2008

    Report

    Report Number
    2134265-2008-02515
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ANALYSIS OF THE RETURNED DEVICE THE EVENT INFO IS CONFIRMED. THE CATHETER WAS RETURNED WITHIN THE GUIDE CATHETER. THE PRESENCE OF DRIED BLOOD WAS NOTED IN THE HUB OF THE MICROCATHETER. A BREAK ON THE CATHETER SHAFT WAS VISIBLE AND THE BRAID WAS EXTENSIVELY STRETCHED. THE BREAK IN THE SHAFT WAS 13.4CM FROM THE PROXIMAL WITH 30.5CM OF BRAID EXPOSED. A 0.0184" MANDREL WAS INSERTED THROUGH THE HUB. THE MANDREL COULD NOT BE ADVANCED PAST THE BREAK IN THE CATHETER SHAFT 13.4CM FROM THE PROXIMAL. THE MANDREL WAS ADVANCED THROUGH THE DISTAL END. THE MANDREL COULD NOT BE ADVANCED DUE TO PRESENCE OF DRIED BLOOD WITHIN THE CATHETER SHAFT. AS THE CATHETER COULD NOT BE REMOVED FROM THE GUIDE CATHETER, A LIMITED DIMENSIONAL INSPECTION WAS PERFORMED. ALL DIMENSIONS WHICH WERE MEASURED WERE FOUND TO BE WITHIN SPEC. THERE WERE NO ISSUES IDENTIFIED IN THE DEVICE HISTORY REVIEW THAT POTENTIALLY RELATE TO THE REPORTED DEFECT. A ROOT CAUSE OF USER/USE ERROR IS ASSIGNED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL EMBOLIZATION PROCEDURE, CATHETER AND GUIDEWIRE COMPATIBILITY ISSUES AND SHREDDING OCCURRED. THE AREA OF TREATMENT WAS THE VISCERAL REGION. THE RENEGADE MICROCATHETER "WOULD NOT ACCEPT THE GUIDEWIRE, BECAME STUCK AND HAD TO BE FORCIBLY REMOVED". BY ATTEMPTING TO FORCIBLY REMOVED THE UNSPECIFIED WIRE, THE RENEGADE MICROCATHETER WAS REMOVED FROM THE PT. UPON EXAMINATION, SOME "SHREDDING" WAS NOTED, HOWEVER, IT WAS NOT CLEAR IF IT WAS FROM THE GUIDE WIRE OR THE MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO ADVERSE EFFECT REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC 18-302 11602620

    Patients

    Seq Age Sex Outcome Treatment
    1