BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE

    MDR report key: 1497335 · Received September 2, 2009

    Report

    Report Number
    1225894-2009-00003
    Event Type
    Malfunction
    Date Received
    September 2, 2009
    Date of Event
    August 3, 2009
    Report Date
    September 2, 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 DISTAL PORTION OF THE LOOP WAS SHEARED OFF APPROXIMATELY 3-5 MM FROM THE DISTAL END OF THE DEVICE. THE LOOP LEGS HAVE 90 DEGREE TIGHT BENDS AT THE SHEARED SURFACE SUGGESTING THE LOOP WAS BENT TIGHTLY PRIOR TO SHEARING. MORE INFO IS NECESSARY TO DETERMINE EXACTLY HOW THE FAILURE OCCURRED AS THE INFO PROVIDED IS NOT CLEAR. THIS HAS BEEN REQUESTED THROUGH VSI.

    Description of Event or Problem · 1

    THE SNARE WAS USED TO TRY TO ENGAGE THE PROXIMAL END OF A SHEARED OFF PORTA CATHETER. THE EXPRO ELITE SNARE WAS ENGAGED, BUCKLED ON ITSELF, AND THEN OPENED UP. THE DOCTOR TORQUED IT TO CATCH THE CATHETER AND WHEN IT WAS TRIED TO BE PULLED BACK, IT WOULDN'T COME BACK SO THE SNARE, CATHETER, ETC. WAS PULLED INTO THE HEART. THERE WAS A PIECE OF THE SNARE FRAGMENT IN THE LUNG AND THE OTHER PART WENT INTO THE RIGHT ATRIUM WHERE THE TIP OF THE SNARE EMBEDDED ITSELF INTO THE RIGHT VENTRICLE WALL. THE TIP WAS NOT RETRIEVED.

    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 Required Intervention