BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK OUTBACK

    MDR report key: 1153340 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02168
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PHYSICIAN EXPERIENCED DIFFICULTY RETRACTING THE NEEDLE DURING ATTEMPTED, TREATMENT OF A TOTALLY OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PT IS A FEMALE. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED PRIOR TO USE. DEPLOYMENT AND RETRACTION WERE VERIFIED PRIOR TO USE. THE PHYSICIAN STATED THAT WHEN HE ATTEMPTED TO RETRACT THE NEEDLE BACK INTO THE CATHETER, THE NEEDLE WOULD NOT RETRACT. WHEN HE SAW THAT THE WIRE WOULD NOT RETRACT, HE PURPOSELY BROKE THE HANDLE OF THE DEVICE AND NOTICED THAT THE INNER SLEEVE WAS NOT ATTACHED TO THE RETRACTION MECHANISM, SO HE GRABBED THE INNER SHEATH AND WAS ABLE TO RETRACT THE NEEDLE WITHOUT DIFFICULTY. DURING REMOVAL OF THE CATHETER, THE PLASTIC DISTAL TIP SEPARATED AND NEEDLE TO BE SNARED OUT OF THE SHEATH. THE PLASTIC TIP WAS SUCCESSFULLY REMOVED. THERE WAS NO INJURY TO THE PT AND THE PROCEDURE WAS ABORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R