BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE HI-FLO MICROCATHETER

    MDR report key: 2013321 · Received March 10, 2011

    Report

    Report Number
    2939204-2011-00107
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRA
    PMA / PMN Number
    K000177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE CATHETER MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE CATHETER NOTED A KINK 7CM FROM THE PROXIMAL END OF THE SHAFT AT THE END OF THE STRAIN RELIEF. A 0.0184IN MANDREL WAS ADVANCED AND SLIGHT RESTRICTION WAS FELT IN THE REGION OF THE KINK, HOWEVER THE MANDREL WAS STILL ABLE TO BE ADVANCED PAST THE KINK TO THE DISTAL END. IT IS PROBABLE THAT THE CATHETER KINKED AS A RESULT OF HANDLING DURING PREPARATION. THE REPORTABLE EVENT OF TIP BREAK COULD NOT BE CONFIRMED, THEREFORE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT THE DISPENSER COIL WAS FLUSHED WITH 10CC OF SALINE AND NO FRICTION WAS FELT REMOVING THE MICROCATHETER FROM THE DISPENSER COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER HAD BROKEN WHERE IT MEETS THE HUB. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER HAD BROKEN WHERE IT MEETS THE HUB. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO 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 M003EU15010R0 12867569

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR