BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 1792030 · Received August 10, 2010

    Report

    Report Number
    2134265-2010-03747
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN MATERIAL PRESENT IN DEVICE. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL PLACEMENT TREATMENT PROCEDURE, A FOREIGN OBJECT WAS FOUND INSIDE THE DEVICE. THE RENEGADE HI-FLO MICRO-CATHETER WAS FLUSHED PRIOR TO USE AND ADVANCED TO THE INTENDED LOCATION. THE PHYSICIAN INSERTED A COIL AND ATTEMPTED TWICE TO ADVANCE IT PAST THE HUB WITHOUT SUCCESS. NEXT, A MICRO-WIRE WAS ADVANCED TOWARDS THE HUB OF THE MICRO-CATHETER AND A BLOCKAGE WAS NOTED. THE PHYSICIAN REMOVED THE RENEGADE FROM THE PATIENT AND A MICRO-WIRE WAS INSERTED IN THE "OPPOSITE END" OF THE CATHETER. AS THE MICRO-WIRE WAS ADVANCED, A SMALL CLEAR PLASTIC ITEM WAS PUSHED OUT OF THE DEVICE. ANOTHER RENEGADE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001183020 12860996

    Patients

    Seq Age Sex Outcome Treatment
    1