BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1063050 · Received June 19, 2008

    Report

    Report Number
    9616099-2008-01556
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 4, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT COMPLETE. ADD'L INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT DURING PREPARATION OF DEVICE THE CANNULA ACTUATION WAS VERIFIED AND AT THIS TIME THE CANNULA WAS UNABLE TO RETRACT INTO THE RE-ENTRY CATHETER. THE OUTER BOX WAS RECEIVED INTACT. THERE WERE NO ANOMALIES SEEN DURING REMOVAL OF DEVICE FROM THE PACKAGE. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. THERE WERE NO KINKS ON DEVICE AND CATHETER WAS PREPPED WITHOUT ANY SLACK. THE INTENDED PROCEDURE WAS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO A CHRONIC TOTAL OCCLUDED (CTO) LESION. THE DEVICE WAS NOT USED IN THE PT AND ANOTHER CTO CATHETER WAS USED FOR THE PROCEDURE. PT-SPECIFIC INFO WAS NOT AVAILABLE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    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 13320621

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK