BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿-35

    MDR report key: 2861016 · Received December 6, 2012

    Report

    Report Number
    2134265-2012-07196
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    September 4, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL INSPECTION DETERMINED THAT AN INTRODUCER SHEATH, DELIVERY WIRE AND .035 INTERLOCK 2D COIL WERE RETURNED INSIDE THE DISPENSER COIL. THE DELIVERY WIRE AND COIL WERE RETURNED INSIDE THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS INSPECTED AND NO ANOMALY WAS NOTED. THE TWIST LOCK WAS FULLY OPENED. THE COIL WAS VISIBLY BROKEN AS THE INTERLOCKING ARM OF THE COIL WAS NOT ATTACHED TO THE COIL BUT WAS ATTACHED TO THE INTERLOCKING ARM OF THE DELIVERY WIRE. THE PROXIMAL END OF THE COIL WAS BUNCHED TOGETHER AND THE COIL AND DELIVERY WIRE WAS REMOVED FROM THE INTRODUCER SHEATH. THE COIL WAS INSPECTED AND WAS FOUND TO BE SEVERELY STRETCHED TOWARDS THE PROXIMAL END. THE STRETCHES AT THE PROXIMAL END OF THE COIL WERE BUNCHED TOGETHER AND WERE GENTLY PRIZED APART TO SHOW THE MAIN COIL INTERLOCKING ARM HAD BEEN PULLED OFF THE COIL. THERE WAS EVIDENCE OF WELDS ON THE COIL AND MAIN COIL INTERLOCKING ARM. THE DELIVERY WIRE WAS INSPECTED AND A KINK WAS PRESENT IN THE MIDDLE OF THE DELIVERY WIRE. MICROSCOPIC INSPECTION DETERMINED THAT THE COIL ZAP TIP SHAPE AND SURFACE WAS SMOOTH AND THE DELIVERY WIRE ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE INTERLOCKING ARM OF THE MAIN COIL WAS INSPECTED AND NO ANOMALY WAS NOTED AND THE INTERLOCKING ARM OF THE DELIVERY WIRE WAS INSPECTED AND NO ANOMALY WAS NOTED. DIMENSIONAL INSPECTION DETERMINED THAT COIL DIMENSIONS THAT COULD BE MEASURED 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 WAS DETERMINED TO BE USER RELATED AS AN INCOMPATIBLE DIAGNOSTIC CATHETER WAS USED WITH THE .035 INTERLOCK COIL. THE .035 INTERLOCK 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. THE INTERLOCKING DELIVERY WIRE DESIGN ALLOWS THE COIL TO BE ADVANCED AND RETRACTED BEFORE FINAL PLACEMENT IN THE VESSEL, THUS AIDING IN MORE CONTROLLED DELIVERY INCLUDING THE ABILITY TO WITHDRAW THE COIL PRIOR TO DEPLOYMENT." AND "THE USE OF OTHER DIAGNOSTIC CATHETERS MAY RESULT IN AN INABILITY TO DELIVER, DEPLOY, OR RECAPTURE THE DEVICE." (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, A COIL WOULD NOT ADVANCE THROUGH A CATHETER. LESION DETAILS ARE UNKNOWN. THIS 6MM X 20CM 2D .035 INTERLOCK COIL WAS ADVANCED THROUGH ANOTHER MANUFACTURER'S CATHETER BUT IT WOULD NOT ADVANCE. THE PROCEDURE WAS CONTINUED WITH ANOTHER OF THE SAME .035 INTERLOCK COIL DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS BROKEN AND THE INTERLOCKING ARM WAS PULLED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363550 0015361917

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER: ANGIO DYNAMIC