BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?-35

    MDR report key: 3874962 · Received June 16, 2014

    Report

    Report Number
    2134265-2014-03281
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION WAS PERFORMED. THE PUSHER WIRE AND THE INTRODUCER SHEATH WERE FOUND TO BE KINKED. ONLY THE COIL WAS RETURNED, THE INTERLOCKING ARM OF THE COIL WAS NOT. THE COIL WAS FOUND TO BE STRETCHED AND KINKED. A MICROSCOPIC INSPECTION WAS PERFORMED. THE COIL ZAP TIP, THE INTERLOCKING ARM OF THE PUSHER WIRE AND THE PUSHER WIRE ZAP TIP WERE INSPECTED AND NO DAMAGE NOTED. THE DIMENSIONS 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 HAS BEEN DETERMINED TO BE USE/USER ERROR AS THE DFU STATES THAT 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2014. IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION OF THE MODERATELY TORTUOUS HYPOGASTRIC ARTERY. AN IMAGER CATHETER WAS POSITIONED AND A 10X40 INTERLOCK COIL WAS DEPLOYED WITHOUT ISSUE. A 8MM X 40CM INTERLOCK¿-35 WAS THEN SELECTED. UPON ADVANCING THE 8X40 INTERLOCK COIL, IT WAS NOTED THAT THE COIL WOULD NOT ADVANCE INTO THE IMAGER CATHETER. A SECOND 8X40 INTERLOCK COIL WAS USED AND THE SAME THING HAPPENED. THE PHYSICIAN STOPPED ADVANCING THE COIL AND INJECTED THE CATHETER FINE AND A WIRE WOULD PASS THROUGH THE CATHETER, BUT THE TWO COILS WERE GETTING BUNCHED UP AT THE TIP OF THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE COIL WAS NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352394 INTERLOCK?-35 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001363770 0014970150

    Patients

    Seq Age Sex Outcome Treatment
    1