BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 2064288 · Received April 20, 2011

    Report

    Report Number
    2134265-2011-01143
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE INTRODUCER SHEATH, PUSHERWIRE AND TORQUE DEVICE WERE RETURNED, HOWEVER, THE COIL WAS NOT RETURNED. THE TWIST LOCK WAS FULLY OPENED. THE PUSHER WIRE WAS KINKED AND STRETCHED AT THE DISTAL END AND DRIED BLOOD WAS PRESENT ALONG THE DISTAL END. THE CORE WIRE WAS BROKEN AT THE DISTAL TRIFLUOROMETHANE (TFE) LAMINATION MATERIAL, 3.7CM FROM THE INTERLOCKING ARM. A MICROSCOPIC INSPECTION OF THE INTERLOCKING ARM OF THE PUSHERWIRE SS COIL REVEALED NO DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE USE ERROR AS INTERMITTENT FLUSH WAS USED DURING THE PROCEDURE. THE DFU STATES "IN ORDER TO ACHIEVE EXCELLENT PERFORMANCE OF THE INTERLOCK FIBERED IDC OCCLUSION SYSTEM AND REDUCE THE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN A) THE MICROCATHETER AND GUIDING CATHETER, AND B) THE MICROCATHETER AND ANY INTRALUMINAL DEVICE. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6), 2011. IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TREATMENT PROCEDURE RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE INTERLOCKING ARM AND DAMAGE TO THE INTERLOCKING ARM WAS NOTED AFTER WITHDRAWAL. THE PHYSICIAN ADVANCED A NON-BSC MICRO-CATHETER CONTAINING THE 4MM X 8CM FIBERED IDC OCCLUSION SYSTEM COIL TO THE LUMBAR VESSEL. THE PHYSICIAN POSITIONED THE MICROCATHETER AND DEPLOYED THE IDC COIL. AS THE PHYSICIAN ATTEMPTED TO WITHDRAW THE IDC LOCKING PUSHER WIRE ARM INTO THE MICRO-CATHETER, RESISTANCE WAS ENCOUNTERED AND DAMAGE TO THE AREA AROUND THE INTERLOCKING PUSHER WIRE ARM WAS NOTED OUTSIDE OF THE PATIENT. THE PHYSICIAN DEPLOYED ADDITIONAL INTERLOCK AND PUSHABLE COILS TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THE DEVICE INVESTIGATION REVEALED THAT THE CORE WIRE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361520 12209603

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER: PROGREAT