BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?

    MDR report key: 3883338 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03293
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE COIL AND PUSHER WIRE WERE NOT INTERLOCKED. THERE WAS NO SS COIL REGION ON THE PUSHER WIRE, APPEARS TO BE BROKEN AT THE DISTAL TFE. THE PUSHER WIRE WAS KINKED DISTALLY, ALMOST BENT BACK ON ITSELF. NO DAMAGE WAS NOTED TO THE COIL. A MICROSCOPIC INSPECTION WAS PERFORMED. THERE WAS NO SS COIL REGION ON THE PUSHER WIRE, APPEARS TO BE BROKEN AT THE DISTAL TFE. THE PUSHER WIRE WAS KINKED DISTALLY, ALMOST BENT BACK ON ITSELF. NO DAMAGE WAS NOTED TO THE COIL. 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 GIVES INSTRUCTIONS ON HOW TO PREVENT FRICTION FROM OCCURRING DURING THE PROCEDURE BY RECOMMENDING THE USE OF A MICRO CATHETER WITH AN INNER DIAMETER OF 0.021IN. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014 IT WAS REPORTED THAT THE COIL WAS UNABLE TO EXIT THE CATHETER AND WAS DETACHED WITHIN THE CATHETER. A 14MM X 30CM INTERLOCK WAS SELECTED TO TREAT THE TARGET LESION LOCATED ON THE OVARIAN VEIN. DURING PROCEDURE, FOUR INTERLOCK COILS WERE ATTEMPTED TO BE INSERTED INSIDE A NON BSC DEVICE. THE FIRST COIL DID NOT EXIT THE CATHETER AND BECAME DETACHED WITHIN THE CATHETER. THE COIL TOGETHER WITH THE CATHETER WAS REMOVED. A 14MM X 30CM INTERLOCK COIL WAS ATTEMPTED TO BE USE WITH ANOTHER NON BSC DEVICE, HOWEVER, SAME RESULT OCCURRED. THE THIRD AND FOURTH COIL WERE USED ON THE TABLE OUTSIDE THE PATIENT THROUGH ANOTHER NON BSC DEVICE. IT WAS THEN NOTED THAT THE COIL WOULD NOT ADVANCE THROUGH THE CATHETER AND THE PHYSICIAN WAS UNABLE TO DEPLOY THE COILS. THE PROCEDURE WAS COMPLETED WITH A NON BSC COIL. THERE WERE NO PATIENT COMPLICATION REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN PUSHER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361379 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361640 16765522

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR