BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO ELITE

    MDR report key: 1501797 · Received September 8, 2009

    Report

    Report Number
    1225894-2009-00004
    Event Type
    Malfunction
    Date Received
    September 8, 2009
    Date of Event
    August 6, 2009
    Report Date
    September 6, 2009
    Manufacturer
    RADIUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL, SO ANALYSIS OF THE DEVICE IS NOT POSSIBLE. PER THE PHYSICIAN'S DESCRIPTION OF THE EVENT, THE SNARE WAS USED TO ATTEMPT RETRIEVAL OF A TIGHTLY WEDGED COIL AND IT WAS IMPOSSIBLE TO RETRIEVE THE COIL. IT IS POSSIBLE THAT THE COIL WAS LOCKED WITHIN THE VESSEL AND/OR POSSIBLY ENTRAPPED BY TISSUE GROWTH. ATTEMPTED RETRIEVAL MOST LIKELY EXCEEDED THE PULL STRENGTH OF THE PRODUCT, WHICH IS APPROX 6 POUNDS. THE IFU CONTRAINDICATES RETRIEVAL OF FOREIGN OBJECTS THAT ARE ENTRAPPED BY TISSUE GROWTH.

    Description of Event or Problem · 1

    THE DOCTOR WAS SNARING A RELATIVELY WEDGED COIL. THE DOCTOR WAS ABLE TO GET THE SNARE AROUND THE COIL AND AS IT WAS PULLED BACK, THE SNARE BROKE OFF. ANOTHER MICRO ELITE SNARE WAS USED TO SNARE THE ORIGINAL SNARE. THE BROKEN PIECE WAS RETRIEVED SUCCESSFULLY, HOWEVER, A PIECE OF THE COIL WAS UNABLE TO BE RETRIEVED AND WAS LEFT IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO ELITE RETRIEVAL SNARE DQY RADIUS MEDICAL TECHNOLOGIES, INC. 10-0598-03 08W15737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention