BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE

    MDR report key: 923360 · Received April 2, 2007

    Report

    Report Number
    6000125-2007-00016
    Event Type
    Malfunction
    Date Received
    April 2, 2007
    Date of Event
    March 5, 2007
    Report Date
    March 8, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK
    Product Code
    DQO
    PMA / PMN Number
    k023681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD OF THE RENEGADE HIFLO CATHETER (BATCH NUMBER 8971851) WAS PERFORMED; NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE CATHETER MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE CATHETER WAS RETURNED FOR EVALUATION AND WAS CONTAINED INSIDE THE DISPENSER. FOUR BREAKS WERE PRESENT ON THE CATHETER SHAFT. THE FIRST BREAK WAS PRESENT 7CM FROM THE PROXIMAL END. THE BRAID WAS EXPOSED AT EACH OF THE BREAKAGE POINTS. SALINE WAS PRESENT IN THE DISPENSER COIL. A FULL DIMENSIONAL CHECK WAS CARRIED OUT AND ALL DIMENSIONS WERE IN SPECIFICATION. A COATING CONFIRMATION TEST WAS CARRIED OUT AND CONFIRMED THE PRESENCE AND INTEGRITY OF THE COATING. THE TEST CONFIRMED THE PRESENCE OF COATING, HOWEVER, SEVERE COATING DAMAGE WAS EVIDENT ALL ALONG THE COATED LENGTH. IT IS LIKELY THAT EXCESSIVE FORCE USED IN ATTEMPTING TO REMOVE THE CATHETER FROM THE DISPENSER COIL CAUSED THE DAMAGE TO THE COATING. THE RETURNED UNIT HAD 4 BREAKS ALONG THE SHAFT. THIS IS ALSO AN INDICATOR THAT EXCESSIVE FORCE WAS APPLIED WHEN REMOVING THE CATHETER FROM THE DISPENSER COIL. INADEQUATE FLUSH ALSO MAY HAVE CONTRIBUTED TO BREAKAGE OF THE CATHETER. IF THE CATHETER IS FLUSHED ADEQUATELY, THE CATHETER SHOULD BE EASILY REMOVED. THE DFU FOR THIS DEVICE STATES: BEFORE REMOVING THE CATHETER OR GUIDEWIRE FROM THEIR CARRIER TUBES, FLUSH THE CARRIER TUBE(S) WITH HEPARINIZED SALINE TO ACTIVATE THE HYDROPHILIC COATING. REPEAT INJECTION IF DIFFICULTY IN REMOVING PRODUCT FROM THE CARRIER TUBE OCCURS. DUE TO THE EXCESSIVE DAMAGE TO THE CATHETER, THE ROOT CAUSE OF THE COMPLAINT HAS BEEN DETERMINED TO BE USER RELATED. POTENTIAL ROOT CAUSES OF THE CATHETER BREAKING ARE INSUFFICIENT FLUSH AND EXCESSIVE FORCE APPLIED WHEN REMOVING THE CATHETER. ALL RENEGADE UNITS ARE 100% INSPECTED FOR "BUMPS, KINKS AND PINCHES" PER THE DIRECTION OF THE FINAL INSPECTION SPECIFICATIONS. BOSTON SCIENTIFIC MANUFACTURING PROCESSES INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THIS REPORTED DEFECT WILL BE MONITORED AND TRENDED THROUGH THE MONTHLY COMPLAINTS REVIEW BOARD. THE FEBRUARY 2007-15 MONTH TREND REPORT FOR ALL COMPLAINT FAILURE MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A RENEGADE CATHETER WAS BEING PREPARED FOR THERAPEUTIC USE ON A FEMALE PATIENT. DURING THE DEVICE PREPARATION, THE CATHETER WAS CHECKED AND THE HOLDING TUBE WAS FLUSHED WITH APPROXIMATELY 10CC'S OF SALINE. THE CLINICIANS REPORTED THAT THE DEVICE WAS REMOVED FROM THE COIL WITH DIFFICULTY, AND WHEN THE DEVICE WAS REMOVED FROM THE COIL, THE PROXIMAL END OF THE CATHETER BROKE APART AND UNWOUND. THE BREAK OCCURRED AT THE SHAFT OF THE CATHETER. THE CLINICIAN OBTAINED ANOTHER DEVICE AND SUCCESSFULLY COMPLETED THE PATIENT PROCEDURE. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE AFFECT ON THE PATIENT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE DQO DQO BOSTON SCIENTIFIC CORK NA 8971851

    Patients

    Seq Age Sex Outcome Treatment
    1 YR