BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1071660 · Received July 7, 2008

    Report

    Report Number
    9616099-2008-01675
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ORIENTING THE "L" MARKER LEG ON THE CATHETER "LT" DIRECTIONAL MARKER BAND UNDER FLUORO TOWARDS THE TARGET RE-ENTRY SITE, INSTEAD OF SEEING AN "L", THE PHYSICIAN SAW THE LETTER "B" WHILE USING AN OUTBACK CATHETER. THE LESION WAS A CTO IN THE LEFT ILIAC ARTERY, AND THE OUTBACK WAS USED OVER AN ASAHI PROWATER GUIDEWIRE. THE DIRECTIONAL MARKER BAND WAS IN THE PROPER POSITION, BUT THE TARGET LESION WAS VERY POORLY VISUALIZED AND IN BAD CONDITION. THEY REMOVED THE OUTBACK, AND ATTEMPTED TO TRY AND USE ANOTHER ONE, BUT COULD NOT GET A GUIDEWIRE BACK TO THE TARGET LESION DUE TO THE BAD CONDITION AND POOR VISIBILITY OF THE VESSEL. THERE WAS NO REPORT OF PATIENT INJURY. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 13366494

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR