BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE

    MDR report key: 921760 · Received March 28, 2007

    Report

    Report Number
    1225894-2007-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2007
    Date of Event
    December 14, 2006
    Report Date
    March 27, 2007
    Manufacturer
    RADIUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    MMX
    PMA / PMN Number
    K021441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL PORTION OF THE SNARE WAS SEVERELY BENT AND CURLED 180 DEGREES ON ITSELF. THE ENTIRE LOOP PORTION HAD SEPARATED FROM THE CORE AT THE JOINT COIL SOLDER ATTACHMENT. THE LOOP AND LOOP LEGS WERE ALSO SEVERELY BENT AND DISTORTED. IT APPEARS THE DEVICE WAS RIGOROUSLY MANIPULATED AND TORQUED WHICH MAY HAVE LED TO FAILURE OF THE SOLDER ATTACHMENT. THIRTY COMPARATIVE STERILE SAMPLES WERE TAKEN FROM 6 DIFFERENT LOTS IN INVENTORY AND ALL PASSED AND EXCEEDED THE PERFORMANCE SPECIFIATION FOR TENSILE AND BREAK STRENGTH.

    Description of Event or Problem · 1

    SNARE WAS USED TO PULL WINE CONTRALATERALLY FROM LEFT ILIAC ARTERY INTO A SHEATH POSITIONED IN THE RIGHT ILIAC ARTERY. THE DISTAL LOOP SEPARATED FROM THE SNARE WHILE TRYING TO PULL THE WINE INTO THE SHEATH. THE DISTAL LOOP WAS RECOVERED WITH A SECOND SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE RETRIEVAL SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. 6600-005 06W-12179

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention