BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 2103660 · Received May 26, 2011

    Report

    Report Number
    2134812-2011-00005
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MMX
    PMA / PMN Number
    K071457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE FAILURE IS UNDETERMINABLE.

    Description of Event or Problem · 1

    DURING A PATIENT PROCEDURE, THE EXPRO ELITE SNARE BECAME DISLODGED AND WAS RETRIEVED USING ANOTHER SNARE. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE SNARE EMBOLECTOMY CATHETER MMX VASCULAR SOLUTIONS, INC. 8402 08W15927

    Patients

    Seq Age Sex Outcome Treatment
    1