BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 1972176 · Received January 27, 2011

    Report

    Report Number
    2939204-2011-00050
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE BROKEN CATHETER SHAFT. A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE CATHETER SHAFT WAS BROKEN IN THREE PLACES ON THE PROXIMAL SECTION; 5.5CM FROM THE HUB WITH 5.3CM OF INNER BRAID EXPOSED, 10.9 CM FROM THE HUB WITH 0.3CM OF INNER BRAID EXPOSED AND 16CM FROM THE HUB WITH 6CM OF INNER BRAID EXPOSED. COATING DAMAGE WAS NOTED DISTAL TO THE BREAKS, THERE WAS NO PEELING OR MISSING COATING. IT IS MOST LIKELY THAT THIS WAS CAUSED WHEN FORCE WAS APPLIED IN AN ATTEMPT TO REMOVE THE DEVICE FROM THE DISPENSER HOOP. DIFFICULTY REMOVING THE DEVICE FROM THE DISPENSER HOOP IS A RESULT OF INADEQUATE FLUSHING OF THE DISPENSER HOOP PRIOR TO REMOVING THE CATHETER. THE LABELING INSTRUCTS THAT THE DISPENSER HOOP SHOULD BE FLUSHED WITH 10CC'S OF HEPARINIZED SALINE TO ACTIVE THE HYDROPHYLIC COATING ON THE CATHETER ALLOWING IT TO BE REMOVED WITHOUT DIFFICULTY. INADEQUATE FLUSHING MAY RESULT IN THE CATHETER ADHERING TO THE SIDES OF THE DISPENSER HOOP AND THE CATHETER MAY BREAK DURING ATTEMPTS TO REMOVE IT. THE DAMAGE NOTED ON THE RETURNED DEVICE IS CONSISTENT WITH INSUFFICIENT FLUSHING OF THE DISPENSER HOOP, THEREFORE THE CAUSE OF THE BROKEN CATHETER SHAFT IS USE/USER ERROR.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE CATHETER WAS BROKEN IN THREE PLACES ON THE PROXIMAL SHAFT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M003182900US0 13813552

    Patients

    Seq Age Sex Outcome Treatment
    1