BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 1931573 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05488
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED PRODUCT ANALYSIS REVEALED THE DEVICE WAS JAMMED INSIDE A GUIDE CATHETER. THE CATHETER WAS MICROSCOPICALLY AND VISUALLY EXAMINED AND 2 BREAKS WERE NOTED AT 35CM AND 45CM FROM THE PROXIMAL END. THE DEVICES WERE SOAKED IN WATER IN AN ATTEMPT TO SEPARATE THEM; HOWEVER, THIS WAS NOT SUCCESSFUL DUE TO THE SHAFT BREAKS. DIMENSIONAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR AS CONTINUOUS FLUSHING WAS NOT MAINTAINED IN THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A VARICOCELE EMBOLIZATION TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED AT A PORTION OF THE DEVICE THAT REMAINS EXTERIOR TO THE PATIENT. THE TARGET LESION WAS A VARICOCELE. A RENEGADE HI-FLO MICROCATHETER WAS PLACED IN THE PATIENT. IT WAS NOTED THAT AN UNKNOWN GLUE WAS UTILIZED WITH THE MICROCATHETER AND INTERMITTENT FLUSHING WAS MAINTAINED DURING THE PROCEDURE. WHEN THE PHYSICIAN WAS WITHDRAWING THE MICROCATHETER, THE SHAFT BROKE CLOSE TO THE HUB, BUT WAS HELD TOGETHER BY THE INNER BRAID. THE MICROCATHETER AND THE GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, PRODUCT ANALYSIS REVEALED SHAFT BREAKS ALONG A PORTION OF THE DEVICE THAT COULD BE INTRODUCED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE HI-FLO MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001182900 13545426

    Patients

    Seq Age Sex Outcome Treatment
    1