BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿-35

    MDR report key: 3061703 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02327
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE COIL WAS SEVERELY STRETCHED AND THE FIBER BUNDLES WERE COVERED IN DRIED BLOOD AND DRIED BLOOD WAS PRESENT ALONG THE STRETCHED SECTION OF COIL. THE INTERLOCKING ARM OF THE COIL HAD BEEN PULLED OFF. ALTHOUGH THERE WAS EVIDENCE OF A WELD ON THE COIL THE INTERLOCKING COIL ARM WAS NOT ATTACHED ON THE RETURNED DEVICE AND APPEARED TO HAVE PULLED OFF. THE INTERLOCKING COIL ARM WAS NOT RETURNED. THERE WAS ALSO A KINK NOTED ON THE DELIVERY WIRE, NO OTHER ANOMALIES WERE NOTED. THE ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE COIL WAS DAMAGED NOT ALL DIMENSIONS COULD BE MEASURED. THE 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 IS USER AS THE DFU STATES: "IN ORDER TO ACHIEVE EXCELLENT PERFORMANCE OF THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM AND REDUCE THE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT THE 5F DELIVERY CATHETER IS FLUSHED VIGOROUSLY BEFORE AND AFTER THE INTRODUCTION OF EACH INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM." "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." "ATTACH A ROTATING HEMOSTATIC VALVE (RHV) TO THE HUB OF THE CATHETER. ATTACH A STOPCOCK TO THE SIDE ARM OF THE RHV AND THEN CONNECT A LINE FOR CONTINUOUS FLUSH OF APPROPRIATE SOLUTION." (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE INTERLOCK COIL STRETCHED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS PROXIMAL SPLENIC ARTERY. UTILIZING INTERMITTENT FLUSH, THE PHYSICIAN HAD A NON-BSC CATHETER PARKED AT THE PROXIMAL SPLENIC ARTERY AND SUCCESSFULLY DEPLOYED 4 NON-BSC COILS. THE PHYSICIAN TRIED TO DEPLOY AN 8MM X 20CM .035 INTERLOCK CUBE COIL, THE COIL DID NOT DETACHED PROPERLY AND GOT JAMMED IN THE CATHETER. THE COIL STRETCHED. THE ENTIRE SYSTEM WAS PULLED OUT. THE PHYSICIAN ADVANCED ANOTHER NON-BSC CATHETER AND TRIED TO DEPLOY A 10MM X 20MM .035 INTERLOCK CUBE COIL AND THE SAME THING HAPPENED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC COIL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER RETURNED ANALYSIS REVEALED THE MAIN COIL INTERLOCKING ARM HAD BEEN PULLED OFF THE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163887 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363760 15214025

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR