BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OUTBACK

    MDR report key: 3022732 · Received March 27, 2013

    Report

    Report Number
    9616099-2013-00188
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    January 1, 2011
    Report Date
    March 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYS ET AL: AORTO-CAVAL FISTULA FORMATION DUE TO USE OF THE OUTBACK RE-ENTRY CATHETER; CARDIOVASCULAR AND (B)(6), 2011, REPORT A CASE OF RETROGRADE SUBINTIMAL ILIAC ANGIOPLASTY/STENT, RESULTING IN AN AORTO-CAVAL FISTULA, DUE TO USE OF THE OUTBACK RE-ENTRY CATHETER. THE PATIENT WAS MANAGED CONSERVATIVELY WITHOUT FURTHER COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE OUTBACK LTD RE-ENTRY CATHETER IS INTENDED TO FACILITATE PLACEMENT AND POSITIONING OF GUIDEWIRES AND CATHETERS WITHIN THE PERIPHERAL VASCULATURE. THIS PRODUCT IS DESIGNED FOR USE BY PHYSICIANS TRAINED IN AND FAMILIAR WITH PERIPHERAL PERCUTANEOUS INTERVENTIONAL TECHNIQUES. VESSEL INJURY IS IDENTIFIED IN THE PRODUCT'S IFU AS A POTENTIAL COMPLICATION. WITH THE LIMITED INFORMATION AVAILABLE AND NO LOT NUMBER AVAILABLE TO CONDUCT A DHR, NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CATALOG AND THE LOT NUMBERS OF THE DEVICE INVOLVED ARE NOT AVAILABLE. THE DEVICE IS THE OUTBACK RE-ENTRY CATHETER. THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS EVENT WAS OBTAINED FROM A REVIEW OF LITERATURE: BAYS ET AL AORTO-CAVAL FISTULA FORMATION DUE TO USE OF THE OUTBACK RE-ENTRY CATHETER; CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE, 2011. ONLY AN ABSTRACT IS AVAILABLE.

    Description of Event or Problem · 1

    BAYS ET AL AORTO-CAVAL FISTULA FORMATION DUE TO USE OF THE OUTBACK RE-ENTRY CATHETER; CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE, 2011, REPORT A CASE OF RETROGRADE SUBINTIMAL ILIAC ANGIOPLASTY/STENT, RESULTING IN AN AORTO-CAVAL FISTULA, DUE TO USE OF THE OUTBACK RE-ENTRY CATHETER. THE PATIENT WAS MANAGED CONSERVATIVELY WITHOUT FURTHER COMPLICATIONS. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125690 UNKNOWN OUTBACK CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention