BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?-35

    MDR report key: 4192724 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06572
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR AS AN INCOMPATIBLE CATHETER WAS USED AND INTERMITTENT FLUSH WAS UTILIZED. THE DFU STATES: "THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY THROUGH A 5F (1.70 MM) OD (0.035 IN [0.89 MM] OR 0.038 IN [0.97 MM] INNER LUMEN) IMAGER¿ II SELECTIVE DIAGNOSTIC CATHETER WITHOUT SIDE FLUSHING HOLES." ADDITIONALLY, THE PREPARATIONS FOR USE SECTION OF THE DFU INSTRUCTS THE USER TO BEGIN CONTINUOUS FLUSH BEFORE INTRODUCING THE COIL INTO THE CATHETER. THE NON-PERFORMANCE OF THIS MAINTENANCE STEP IS A CONTRIBUTORY FACTOR TO THE ADDED RESISTANCE IN THE CATHETER AND THE INABILITY TO SUCCESSFULLY DEPLOY THE COIL. BSC ID: A00475948 TW# 3362710

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS STUCK AND PROTRUDING FROM THE CATHETER'S TIP UPON REMOVAL. A 10MM X 40CM INTERLOCK¿-35 WAS SELECTED AND ADVANCED TO EMBOLIZE AN ABDOMINAL AORTIC ANEURYSM IN THE SEVERELY TORTUOUS INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE COIL THROUGH A 5F .038 NON BSC CATHETER. IT WAS NOTED THAT THE COIL WOULD NOT FULLY DEPLOY OUT OF THE CATHETER AS THE COIL WAS STUCK INSIDE THE CATHETER. THE COIL AND CATHETER WERE REMOVED AS A UNIT WITH PART OF THE COIL PROTRUDING OUT OF THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH AN 018 COIL SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672999 INTERLOCK?-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001363800 17100967

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 5FR .038 GLIDE CATHETER