BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 1230445 · Received November 7, 2008

    Report

    Report Number
    2134265-2008-04257
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POPLITEAL ANEURYSM PROCEDURE, ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS GAINED THROUGH A CONTRALATERAL APPROACH. UPON ATTEMPTING TO ADVANCE THE RENEGADE HI-FLO MICROCATHETER OVER ANOTHER MFR'S GUIDE WIRE AND GUIDE CATHETER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN REMOVED THE GUIDE WIRE, GUIDE CATHETER AND THE RENEGADE HI-FLO MICROCATHETER TOGETHER WITHOUT INCIDENT. IT WAS FURTHER REPORTED THAT THE RENEGADE HI-FLO MICROCATHETER WAS "FRAGMENTED" AT AN UNSPECIFIED LOCATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PT INJURIES OR COMPLICATIONS. THE PT'S STATUS WAS REPORTED AS "FINE." IT IS NOTED THAT THIS PRODUCT WAS USED AFTER THE EXPIRATION DATE.

    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 0004731479

    Patients

    Seq Age Sex Outcome Treatment
    1 6R SHEATH| 5FR GUIDE CATHETER