BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS 2.5-5 RX US

    MDR report key: 1001359 · Received February 20, 2008

    Report

    Report Number
    1220452-2008-00010
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NFA
    PMA / PMN Number
    K023878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE SUBJECT DEVICE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORD WILL BE PERFORMED. DEVICE DISCARDED - NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE OCCLUSION BALLOON WIRE KINKED RESULTING IN DIFFICULTY IN DEFLATING THE OCCLUSION BALLOON. THE PHYSICIAN INSERTED THE OCCLUSION BALLOON WIRE INTO THE PATIENT AND INFLATED THE OCCLUSION BALLOON TO OCCLUDE THE VESSEL. AT SOME POINT DURING THE PROCEDURE, THE OCCLUSION BALLOON WIRE KINKED RESULTING IN THE OCCLUSION BALLOON REMAINING INFLATED. THE PHYSICIAN ATTEMPTED TO THEN DEFLATE THE OCCLUSION BALLOON; HOWEVER, THE KINK IN THE OCCLUSION BALLOON WIRE WOULD NOT ALLOW THE OCCLUSION BALLOON TO DEFLATE. THE PHYSICIAN USED THE METHOD REFERENCED IN THE INSTRUCTION FOR USE AND CUT THE OCCLUSION BALLOON WIRE AND DEFLATED THE OCCLUSION BALLOON. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER TO COMPLETE THE CASE. THE PATIENT IS REPORTED TO BE FINE. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS 2.5-5 RX US NFA MEDTRONIC INC. NA 0000545936

    Patients

    Seq Age Sex Outcome Treatment
    1 NA