BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE

    MDR report key: 2555688 · Received August 19, 2009

    Report

    Report Number
    1225894-2009-00005
    Event Type
    Malfunction
    Date Received
    August 19, 2009
    Date of Event
    July 22, 2009
    Report Date
    August 19, 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

    THE LOOP IS FRACTURED FROM THE CORE IMMEDIATELY DISTAL TO THE CORE/LOOP ATTACHMENT JOINT. THE PROXIMAL ENDS OF THE SNARE LOOP ARE PERMANENTLY BENT AT GREATER THAN 90 DEGREE ANGLES APPROX 4 MM DISTAL TO THE BREAK LOCATION, WHICH COINCIDES WITH THE DISTAL END OF THE OUTER SHEATH. THE OUTER SHEATH AND INNER CORE WIRE ARE FULLY INTACT. THE INNER CORE WAS EXTENDED COMPLETELY FORWARD WITHIN THE OUTER SHEATH. IT APPEARS THAT THE LOOP OF THE SNARE WAS BENT 180 DEGREES BACKWARDS OVER THE OUTER SHEATH DISTAL END AND THE SNARE WAS MANIPULATED AND TORQUED WITH THE LOOP IN THE FULLY EXPANDED AND BENT POSITION. FRACTURE OF THE LOOP LEGS MOST LIKELY OCCURRED FROM REPEATED TORQUING AND MANIPULATING OF THE SNARE WITH THE LOOP FULLY DEPLOYED AND BENT WHILE LOCKED ONTO THE PORT CATHETER OR WITHIN THE VESSEL. THERE IS NO INFO ON THE VESSEL DIAMETER, HOWEVER, SEVERE BENDING WOULD BE NECESSARY TO CAUSE PERMANENT DEFORMATION OF THE LOOP WIRES. INSTRUCTIONS FOR USE DESCRIBES RETRACTING THE LOOP INTO THE OUTER SHEATH DURING MANIPULATION PROCEDURES.

    Description of Event or Problem · 1

    A 15MM EXPRO ELITE SNARE (MODEL #8402) WAS USED TO ASSIST IN GRASPING A PORT CATHETER FOR POSITIONING. THE SNARE WAS BEING ROTATED TO GRASP THE CATHETER WHEN IT WAS NOTICED THAT THE HELICAL TIP HAD SEPARATED FROM THE CATHETER. ACCORDING TO THE DOCTOR, THE HELICAL TIP WAS ROTATING WITH THE CATHETER AND THERE WAS NO RESISTANCE. AT FIRST THE TIP DID NOT MOVE BUT THEN STARTED TO MIGRATE TOWARDS THE HEART. AN ENSNARE WAS USED TO CAPTURE THE EXPRO SNARE TIP. IT IS UNK WHY THE TIP WAS SEPARATED FROM THE CATHETER BECAUSE THERE WAS NO RESISTANCE WHEN THE CATHETER AND TIP WERE ROTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE RETRIEVAL SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. 10-0609-01 08W15297

    Patients

    Seq Age Sex Outcome Treatment
    1