BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE

    MDR report key: 1497379 · Received September 2, 2009

    Report

    Report Number
    1225894-2009-00002
    Event Type
    Malfunction
    Date Received
    September 2, 2009
    Date of Event
    July 31, 2009
    Report Date
    August 31, 2009
    Manufacturer
    RADIUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    MMX
    PMA / PMN Number
    K071457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE LOOP LEG IS FRACTURED IMMEDIATELY DISTAL TO THE CORE/LOOP ATTACHMENT JOINT AND THE SECOND LOOP LEG IS FRACTURED APPROXIMATELY 2.5 MM DISTAL TO THE CORE/LOOP ATTACHMENT JOINT. THE LOOP LEG ENDS ARE STRAIGHT AS IS THE CORE END ADJACENT TO THE FRACTURE. THE OUTER SHEATH AND INNER CORE WIRE ARE FULLY INTACT. THE FRACTURE OF THE LOOP LEGS OCCURRED WITHIN THE OUTER SHEATH AND WAS MOST LIKELY DUE TO SEVERE AND REPEATED TORQUING AND MANIPULATING OF THE SNARE WITH THE LOOP LOCKED ONTO THE IVC FILTER. THERE IS NO INFORMATION REGARDING THE TYPE OF THE FILTER OR THE LENGTH OF TIME THE FILTER WAS IMPLANTED. IT IS POSSIBLE THAT THE FILTER WAS ENTRAPPED BY TISSUE GROWTH WITHIN THE IVC. INSTRUCTIONS FOR USE CONTRAINDICATE REMOVING FOREIGN BODIES THAT ARE ENTRAPPED BY TISSUE GROWTH. INFORMATION ON THE MAKE OF FILTER AND THE TERM OF IMPLANT HAS BEEN REQUESTED OF VSI.

    Description of Event or Problem · 1

    TIP OF SNARE BROKE AND HAD TO BE PULLED OUTSIDE OF BODY DURING AN IVC FILTER RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE RETRIEVAL SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. 10-0610-01 08W15631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention