BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPORTAP

    MDR report key: 2221474 · Received August 17, 2011

    Report

    Report Number
    1220452-2011-00059
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXE
    PMA / PMN Number
    K081573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS CURRENTLY BEING PERFORMED ON THE RETURNED DEVICE. ONCE THE EVAL IS COMPLETED, A F/U MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT DURING AN ACUTE MYOCARDIAL INFARCTION, THE PHYSICIAN INSERTED THE GUIDE WIRE INTO THE PT. THE PHYSICIAN INSERTED THE ASPIRATION CATHETER ONTO THE WIRE AND ADVANCED IT FORWARD INTO THE VESSEL. THE PHYSICIAN ENCOUNTERED RESISTANCE AND COULD NOT BE ADVANCE TO CATHETER TO THE POINT OF OCCLUSION. THE PHYSICIAN THEN ATTEMPTED TO WITHDRAW THE ASPIRATION CATHETER HOWEVER, WAS NOT ABLE TO. THE PHYSICIAN THEN REMOVED THE ASPIRATION CATHETER AND THE .014 CORONARY GUIDE WIRE. A NEW WIRE WAS INSERTED INTO THE VESSEL AND THE CASE WAS COMPLETED VIA BALLOON ANGIOPLASTY. UPON REMOVAL OF THE ASPIRATION CATHETER IT WAS NOTED THAT THE MARKER BAND DETACHED FROM THE ASPIRATION CATHETER. THE MARKER BAND REMAINED IN THE MID RIGHT CORONARY ARTERY. THE MARKER BAND IS EVIDENT ON X-RAY AND MIGRATED DISTALLY TO A RV3 VERY SMALL BRANCH. THE PHYSICIAN FEELS IT IS IN A POSITION THAT WILL NOT CAUSE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPORTAP DXE MEDTRONIC INC. NA 0005724495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization