BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE FIBER BRAIDED MICROCATHETER

    MDR report key: 1904491 · Received November 22, 2010

    Report

    Report Number
    2939204-2010-01111
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K973645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE DEVICE FOUND THAT THE CATHETER SHAFT WAS BROKEN 8.4CM FROM THE HUB WITH 11CM OF BRAID EXPOSED. FURTHER INVESTIGATION CONFIRMED THAT THERE WAS NO PEELING OR MISSING COATING, HOWEVER COATING DAMAGE WAS EVIDENT DISTAL TO THE BREAKS. THE CATHETER BREAKAGE DURING REMOVAL FROM THE DISPENSER COIL IS CONSISTENT WITH INSUFFICIENT FLUSH OF THE DISPENSER HOOP DURING PREPARATION. THE LABELING STATES: "BEFORE REMOVING THE MICROCATHETER FROM THE CARRIER TUBE, FLUSH THE CARRIER TUBE WITH HEPARINIZED SALINE TO WET THE HYDROPHILIC SEGMENT OF THE MICROCATHETER." MOST LIKELY EXCESSIVE FORCE USED IN ATTEMPTING TO REMOVE THE MICROCATHETER FROM THE DISPENSER COIL CAUSED THE CATHETER BREAKAGE AND COATING DAMAGE. THEREFORE, IT WAS DETERMINED THAT USER ERROR CONTRIBUTED TO THE CATHETER BREAKAGE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE CATHETER SHAFT WAS BROKEN. THIS OCCURRED OUTSIDE THE PATIENT SO THERE WAS NO DIRECT CONTACT WITH THE PATIENT AND NO CLINICAL CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE FIBER BRAIDED MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182590 13399323

    Patients

    Seq Age Sex Outcome Treatment
    1