BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 2033720 · Received March 30, 2011

    Report

    Report Number
    2134265-2011-01124
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COIL WAS RETURNED JAMMED INSIDE THE RENEGADE HI FLO CATHETER. THE DISTAL SECTION OF THE COIL AND INTERLOCKING ARM OF THE PUSHER WIRE WERE PROTRUDING FROM THE CATHETER DISTAL TIP. THE PUSHER WIRE WAS SEVERELY KINKED AT THE RHV WHICH WAS ATTACHED TO THE CATHETER. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE COIL AND PUSHERWIRE WITHOUT SUCCESS AS THEY WERE JAMMED INSIDE THE CATHETER. THE CATHETER WAS CUT AND DRIED BLOOD WAS REMOVED DURING CUTTING. AS THE PUSHER WIRE AND COIL WERE BEING ADVANCED A SIGNIFICANT AMOUNT OF BLOOD WAS REMOVED. THE COIL WAS INSPECTED AND FOUND TO BE STRETCHED. MICROSCOPIC INSPECTION REVEALED THE ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE INTERLOCKING ARM OF THE MAIN COIL WAS INSPECTED AND NO DAMAGE NOTED. THE INTERLOCKING ARM OF THE PUSHER WIRE SS COIL WAS INSPECTED AND NO DAMAGE WAS NOTED. DEVICE DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER RELATED AS THE USER DID NOT COMPLY WITH THE F-IDC DFU. THE DFU STATES "THE INTERLOCK FIBERED IDC OCCLUSION COIL IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY WITH A 0.021 IN (0.53 MM) INNER DIAMETER MICROCATHETER (E.G. RENEGADE MICROCATHER WITH ONE OR TWO RADIOPAQUE RO TIP MARKERS.)" (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2011-01063. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE A COIL DETACHED AND BECAME STUCK IN THE MICROCATHETER. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. THE 135/10 0.027 RENEGADE HI-FLO MICROCATHETER WAS ADVANCED TO THE TARGET LOCATION. THREE UNSPECIFIED COILS WERE SUCCESSFULLY DEPLOYED. A 3MM X 12CM FIBERED COIL SYSTEM WAS SELECTED FOR USE AND DURING ADVANCEMENT THE COIL DETACHED AND REMAINED INSIDE THE DISTAL END OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH THE COILS THAT HAD BEEN PLACED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS UNAVAILABLE. RETURNED PRODUCT ANALYSIS REVEALED THE COIL AND PUSHER WIRE WERE PROTRUDING FROM THE TIP OF THE MICROCATHETER.

    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 M001361510 0013650049

    Patients

    Seq Age Sex Outcome Treatment
    1