BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 1998887 · Received February 23, 2011

    Report

    Report Number
    2134265-2011-00299
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: VISUAL ANALYSIS REVEALED THE DISPENSER COIL, INTRODUCER SHEATH, PUSHER WIRE AND COIL WERE RETURNED. THE COIL AND PUSHER WIRE WERE INSIDE THE INTRODUCER SHEATH. THE ARMS OF THE PUSHER WIRE AND COIL WERE INTERLOCKED IN THE INTRODUCER SHEATH. THE COIL WAS REMOVED FROM THE DISTAL TIP WITH RESISTANCE. THE PUSHER WIRE WAS INSPECTED AND SEVERAL KINKS WERE PRESENT TOWARDS THE DISTAL END. A SEVERE KINK WAS PRESENT 1.9CM FROM THE DISTAL END OF THE PUSHER WIRE. THE CORE WIRE WAS BROKEN BETWEEN THE DISTAL AND MID SOLDER JOINTS. THE COIL AND INTRODUCER SHEATH WERE INSPECTED AND NO ANOMALIES WERE NOTED. MICROSCOPIC INSPECTION REVEALED THE ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE INTERLOCKING ARM OF THE MAIN COIL AND THE INTERLOCKING ARM OF THE PUSHER WIRE SS COIL WERE INSPECTED AND NO DAMAGE WAS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TREATMENT PROCEDURE, THE COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER. WHILE TREATING A PATIENT FOR AN ABDOMINAL AORTIC ANEURYSM, A RENEGADE 2M MICROCATHETER WAS UTILIZED FOR COIL DEPLOYMENT. CONTINUOUS FLUSHING WAS MAINTAINED. TWO 14MM X 30CM F-IDC 2D COILS WERE DEPLOYED WITHOUT ISSUE. A THIRD COIL OF THE SAME SIZE WAS INSERTED INTO THE MICROCATHETER, BUT BECAME STUCK IN THE PROXIMAL END OF THE CATHETER AND WAS THEREFORE REMOVED. A 10MM X 30CM F-IDC 2D WAS THEN ADVANCED AND RESISTANCE WAS MET IN THE HUB OF THE MICROCATHETER. THIS COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER ADDITIONAL F-IDC COILS, AS WELL AS PUSHABLE COILS, WERE DEPLOYED WITH THE RENEGADE 2M. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE PUSHER WIRE OF THE 10MM X 30CM F-IDC 2D WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361600 13623867

    Patients

    Seq Age Sex Outcome Treatment
    1 RENEGADE 2M MICROCATHETER| 2 - 14MM X 30CM F-IDC 2D COILS| 5F SG GUIDING CATHETER