BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 1904560 · Received November 22, 2010

    Report

    Report Number
    2939204-2010-01118
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF SHAFT BREAK. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT THE DISPENSER HOOP WAS FLUSHED WITH SALINE PRIOR TO TRYING TO REMOVE IT FROM THE DISPENSER HOOP AND THAT THE PROXIMAL END OF CATHETER STRETCHED AS IT WAS PULLED OUT OF THE DISPENSER HOOP. VISUAL ANALYSIS OF THE RETURNED DEVICE SHOWED THE CATHETER SHAFT WAS BROKEN 7CM FROM THE HUB WITH 5.4CM OF BRAID EXPOSED. IN ADDITION, COATING DAMAGE WAS EVIDENT DISTAL TO THE BREAK. EXCESSIVE FORCE USED IN ATTEMPTING TO REMOVE THE MICROCATHETER FROM THE DISPENSER COIL MOST LIKELY CAUSED THE DAMAGE TO THE COATING. BASED ON THE INFORMATION AND ANALYSIS OF THE DEVICE IT WAS DETERMINED THAT THIS FAILURE OCCURED AS A RESULT OF LACK OF ADEQUATE FLUSH TO THE DISPENSER COIL BEFORE REMOVING THE CATHETER. FLUSHING THE DISPENSER COIL WITH 10CC'S OF SALINE ACTIVATES THE HYDROPHILIC COATING ON THE CATHETER ALLOWING THE CATHETER TO BE REMOVED WITHOUT DIFFICULTY. IF INADEQUATE FLUSH IS USED THE CATHETER MAY ADHERE TO THE SIDES OF THE DISPENSER COIL AND MAY BREAK WHEN THE PHYSICIAN ATTEMPTS TO REMOVE IT. THE DAMAGES TO THE RETURNED DEVICE ARE CONSISTENT WITH INSUFFICIENT FLUSH OF THE DISPENSER HOOP. EXCESSIVE FORCE USED IN ATTEMPTING TO REMOVE THE MICROCATHETER FROM THE DISPENSER COIL MOST LIKELY CAUSED THE DAMAGE NOTED TO THE COATING. A ROOT CAUSE OF USER/USE ERROR WILL BE ASSIGNED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED THE CATHETER'S SHAFT WAS BROKEN. NO IMPACT OR CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M003182900US0 12837995

    Patients

    Seq Age Sex Outcome Treatment
    1