BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 2141728 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02451
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE DELIVERY WIRE AND COIL WERE RETURNED WITH THE CATHETER USED IN THE PROCEDURE. AN EXAMINATION OF THE RETURNED DEVICES FOUND THAT THE DISTAL TIP OF THE COIL WAS PROTRUDING FROM THE CATHETER. 71CM OF THE DELIVERY WIRE WAS PROTRUDING FROM THE PROXIMAL END OF THE CATHETER. A SEVERE KINK WAS NOTED 74.1CM FROM THE PROXIMAL END OF THE DELIVERY WIRE. AN ATTEMPT TO ADVANCE THE COIL IN THE CATHETER WAS UNSUCCESSFUL. THE DELIVERY WIRE WAS PULLED BACK THROUGH THE PROXIMAL END OF THE CATHETER WITHOUT RESISTANCE. UPON REMOVAL OF THE WIRE, IT WAS NOTED THE INTERLOCKING ARM OF THE COIL WAS ATTACHED TO THE INTERLOCKING ARM OF THE DELIVERY WIRE. THE CATHETER WAS CUT FROM AROUND THE COIL TO RELEASE THE COIL. THE COIL WAS REMOVED AND FOUND TO BE SEVERELY STRETCHED AT THE PROXIMAL END. THE INTERLOCKING ARM WAS NOT ATTACHED. THE COIL WAS KINKED AND BLOOD WAS PRESENT ON THE FIBER BUNDLES. THE PROXIMAL END OF THE COIL WAS INSPECTED AND FOUND TO BE SEVERELY BENT. THERE WAS EVIDENCE OF A WELD ON THE COIL. THE INTERLOCKING COIL ARM WAS REMOVED FROM THE DELIVERY WIRE ARM AND INSPECTED. THERE WAS EVIDENCE OF A WELD ON THE COIL ARM. THE ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE INTERLOCKING ARM OF THE MAIN COIL WAS INSPECTED AND WHILE NO DAMAGE WAS NOTED, 3 INDENTATIONS WERE PRESENT ON THE ARM WHICH INDICATES THE ARM HAD BEEN WELDED ONTO THE COIL. THE INTERLOCKING ARM OF THE DELIVERY WIRE WAS INSPECTED AND NO DAMAGE NOTED. THE DELIVERY WIRE DIMENSIONS WERE FOUND TO BE IN SPECIFICATION. AS THE COIL WAS DAMAGED, NOT ALL DIMENSIONS COULD BE MEASURED. THE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE CONTINUOUS FLUSH DIRECTIONS OF THE DFU ("IN ORDER TO REDUCE THE RISK OF COMPLICATIONS, A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION SHOULD BE MAINTAINED THROUGH THE CATHETER"). ALSO, "THE INTERLOCK- 35 FIBERED OCCLUSION SYSTEM IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY USING AN IMAGER II DIAGNOSTIC CATHETER. THE USE OF OTHER DIAGNOSTIC CATHETERS MAY RESULT IN AN INABILITY TO DELIVER, DEPLOY OR RECAPTURE THE DEVICE. THE INTERLOCK- 35 FIBERED OCCLUSION SYSTEM WILL ENCOUNTER SIGNIFICANT RESISTANCE WHEN ADVANCEMENT THROUGH A SOFT WALL DELIVERY CATHETER IS ATTEMPTED." (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, COIL ADVANCEMENT DIFFICULTIES OCCURRED. THE INDICATION OF PROCEDURE WAS FOR BLEEDING. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT INTERNAL JUGULAR. THE TARGET VESSEL WAS THE MODERATELY TORTUOUS ESOPHAGEAL VARICES. THIS 15MM X 25CM .035 INTERLOCK COIL WAS ADVANCED THROUGH ANOTHER MANUFACTURERS' .035" MICROCATHETER; HOWEVER, THE COIL WOULD NOT EXIT THE TIP OF THE CATHETER. THE CATHETER AND COIL SYSTEM WERE REMOVED FROM THE PATIENT TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A .018 INTERLOCK COIL. INTERMITTENT FLUSH WAS MAINTAINED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE COIL INTERLOCKING ARM WAS BROKEN AND THE DISTAL TIP OF THE COIL WAS PROTRUDING FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCKING DETACHABLE COIL DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363810

    Patients

    Seq Age Sex Outcome Treatment
    1 .035" NB COBRA2 COOK CATHETER