BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1161457 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02221
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Removal / Correction Number
    1016427-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    A CROSSOVER PROCEDURE TO CONDUCT A SUB-INTIMAL RECANALIZATION OF A 15CM OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS BEING CONDUCTED. AFTER HAVING THE OUTBACK CATHETER IN THE CORRECT LOCATION, THE PHYSICIAN PULLED OUT THE NEEDLE TO GET ACCESS TO THE VESSEL LUMEN. THE FIRST ATTEMPT WAS NOT SUCCESSFUL AND THE PHYSICIAN WANTED TO RETRIEVE THE NEEDLE BACK IN TO THE CATHETER FOR A SECOND TRY, HOWEVER, THE NEEDLE DID NOT GO BACK INTO THE CATHETER. THE "NEEDLE GOT STUCK." THE PHYSICIAN THEN PULLED BACK THE OUTBACK UNTIL THE SHEATH WAS COMPLETELY OVER THE CATHETER.

    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 13252415

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR