BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS 2-5RX-6F

    MDR report key: 1431648 · Received May 4, 2009

    Report

    Report Number
    1220452-2009-00022
    Event Type
    Malfunction
    Date Received
    May 4, 2009
    Date of Event
    April 28, 2009
    Report Date
    April 28, 2009
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NFA
    PMA / PMN Number
    K023878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE OCCLUSION BALLOON WIRE KINKED, RESULTING IN THE OCCLUSION BALLOON REMAINING INFLATED. THE PHYSICIAN INSERTED THE OCCLUSION BALLOON WIRE INTO THE PT AND INFLATED THE OCCLUSION BALLOON TO OCCLUDE THE VESSEL. AT SOME POINT DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE OCCLUSION BALLOON WIRE INTO THE ADAPTER IN AN ATTEMPT TO DEFLATE THE OCCLUSION BALLOON, AND THE WIRE BECAME KINKED RESULTING IN THE OCCLUSION BALLOON REMAINING INFLATED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE OCCLUSION BALLOON FROM THE PT AND CONTINUE THE PROCEDURE WITH A NEW DEVICE. THE PT IS REPORTED TO BE FINE. AN ATTEMPT TO OBTAIN ADD'L INFO ABOUT THE CASE HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS 2-5RX-6F NFA MEDTRONIC INC. NA 0000778078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA