BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1002205 · Received February 21, 2008

    Report

    Report Number
    9616099-2008-00421
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 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

    Description of Event or Problem · 1

    DURING A CTO PROCEDURE IN THE SFA, THE PHYSICIAN SUCCESSFULLY RE-ENTERED THE TRU-LUMEN OF THE TARGET VESSEL USING AN OUTBACK CATHETER OVER AN ASAHI GRAND SLAM GUIDEWIRE. UPON ATTEMPTING TO REMOVE THE OUTBACK OVER THE WIRE, THE PHYSICIAN INADVERTENTLY LOST POSITION WITH HIS WIRE, AND THEN DECIDED TO REMOVE BOTH THE WIRE AND OUTBACK FROM THE PATIENT. THE PHYSICIAN THEN RAN A NEW, UNKNOWN WIRE TO THE LESION SITE, AND WITHOUT RE-FLUSHING THE OUTBACK, RAN THE OUTBACK OVER THIS NEW WIRE, AND AGAIN RE-ENTERED THE TRU-LUMEN. HOWEVER, THIS TIME, HE WAS UNABLE TO RETRACT THE NEEDLE OF THE OUTBACK FROM THE TRU-LUMEN. THE PHYSICIAN THEN DECIDED TO TAKE THE PATIENT TO SURGERY TO BYPASS THE CTO AND REMOVE THE OUTBACK DEVICE. THIS WAS SUCCESSFUL IN BOTH RESPECTS, AND THE PATIENT SUFFERED NO ADVERSE SEQUELAE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. 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 13315066

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ASAHI GRAND SLAM GUIDEWIRE| 7F COOK BALKIN SHEATH