BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS 2.5-5 RX US

    MDR report key: 1692562 · Received May 12, 2010

    Report

    Report Number
    1220452-2010-00022
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 5, 2010
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NFA
    PMA / PMN Number
    K023878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 HAD RUPTURED. THE PHYSICIAN INSERTED THE OCCLUSION BALLOON WIRE INTO THE PT. THE PHYSICIAN INFLATED AND DEFLATED THE OCCLUSION BALLOON TO OCCLUDE THE VESSEL SUCCESSFULLY. AFTER THE PROCEDURE, THE PHYSICIAN NOTED THAT THERE WAS BLOOD THAT HAD BACK FLOWED INTO THE OCCLUSION BALLOON DEVICE INDICATING AT SOME POINT THE BALLOON RUPTURED. NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS 2.5-5 RX US NFA MEDTRONIC INC. NA 0001856327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA