BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE? HI-FLO? KIT

    MDR report key: 4153209 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06172
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    July 29, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). DEVICE EVALUATED BY MFR: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION WAS PERFORMED AND FOUND A BREAK IN THE SHAFT AT 16.5 CM FROM THE HUB. THE BRAID WAS EXPOSED FROM 16.5 CM FROM THE HUB UP TO 24.5 CM FROM THE HUB. THE CATHETER SHAFT WAS REMOVED FROM THE HOOP WITH NO RESISTANCE AND INSPECTED. NO OTHER DEFECTS WERE NOTED. A COATING CONFIRMATION TEST WAS CARRIED OUT TO CHECK THE PRESENCE AND INTEGRITY OF THE COATING AND REVEALED THAT THE PRESENCE OF COATING AND COATING DAMAGE WAS EVIDENT ALONG THE COATED LENGTH. EXCESSIVE FORCE USED IN ATTEMPTING TO REMOVE THE MICROCATHETER FROM THE DISPENSER COIL MOST LIKELY CAUSED THE DAMAGE TO THE COATING. THERE WAS NO PEELING OR MISSING COATING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. A 135/10 RENEGADE¿ HI-FLO¿ KIT WAS SELECTED TO TREAT THE TARGET LESION. AFTER UNPACKING, IT WAS NOTICED THAT THE DEVICE WAS FRACTURED 8 TO 9CM AWAY FROM THE HUB. NO ISSUES WITH THE PACKAGE PRIOR TO USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS FOUND TO BE BROKEN AT 16.5CM FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630588 RENEGADE? HI-FLO? KIT CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC - CORK M001183020 16785420

    Patients

    Seq Age Sex Outcome Treatment
    1