BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?-35

    MDR report key: 3052694 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02301
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A MAIN COIL WAS RETURNED. THE FIBER BUNDLES WERE COVERED IN DRIED BLOOD SO MUCH SO THAT THEY HAD MATTED TO EACH OTHER. THE DELIVERY WIRE WAS FOUND TO BE KINKED INDICATING A RESISTANCE WAS MET DURING THE PROCEDURE. THE COIL WAS STRETCHED AND KINKED. THE COIL WAS IMMERSED IN WARM WATER IN ORDER TO REMOVE THE DRIED BLOOD AND TO SEPARATE THE FIBER BUNDLES FOR ANALYSIS. THE INTERLOCKING ARM WAS BROKEN OFF THE COIL. THE WELD MARKS FROM WHERE THE INTERLOCKING ARM WAS WELDED DURING MANUFACTURING WERE PRESENT. THE COIL ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE INTERLOCKING ARM OF THE MAIN COIL WAS NOT RETURNED FOR ANALYSIS. THE INTERLOCKING ARM OF THE DELIVERY WIRE WAS INSPECTED AND NO DAMAGE NOTED. AS THE COIL WAS DAMAGED NOT ALL DIMENSIONS COULD BE MEASURED. THE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS CONTINUOUS FLUSH WAS NOT MAINTAINED DURING THE PROCEDURE. THE PREPARATIONS FOR USE SECTION OF THE 035 INTERLOCK DFU INSTRUCTS THE USER TO BEGIN CONTINUOUS FLUSH BEFORE INTRODUCING THE COIL INTO THE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE A COIL DETACHED PREMATURELY. THE TARGET LOCATION WAS LOCATED IN THE PORTAL VEIN. THE 8MM X 20CM .035 INTERLOCK COIL CUBE WAS ADVANCED WITHIN AN IMAGER CATHETER. DURING WITHDRAWAL THE COIL "DEPLOYED BY ITSELF SHREDDING". THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE A COIL DETACHED PREMATURELY. THE TARGET LOCATION WAS LOCATED IN THE PORTAL VEIN. THE 8MM X 20CM .035¿ INTERLOCK COIL CUBE WAS ADVANCED WITHIN AN IMAGER CATHETER. DURING WITHDRAWAL THE COIL ¿DEPLOYED BY ITSELF SHREDDING¿. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154685 INTERLOCK?-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363760 15214025

    Patients

    Seq Age Sex Outcome Treatment
    1