BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OUTBACK

    MDR report key: 2003682 · Received March 1, 2011

    Report

    Report Number
    9616099-2011-00146
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE INFORMATION: SHIN, SUSANNA H ET AL. 2011. "LIMITATIONS OF THE OUTBACK LTD RE-ENTRY DEVICE IN FEMOROPOPLITEAL CHRONIC TOTAL OCCLUSIONS." JOURNAL OF VASCULAR SURGERY. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    SHIN ET AL IN THE JOURNAL FOR VASCULAR SURGERY; LIMITATIONS OF THE OUTBACK LTD RE-ENTRY DEVICE IN FEMOROPOPLITEAL CHRONIC TOTAL OCCLUSIONS, DOI: 10.1016/J.JVS.2010.10.27; REPORT THAT DURING A RETROSPECTIVE REVIEW OF PATIENTS WITH FEMOROPOPLITEAL CTO FROM (B)(6) 2006 TO (B)(6) 2009, THE OUTBACK CATHETER CREATED AN ARTERIOVENOUS FISTULA. NO INTERVENTION WAS PERFORMED AND NO ADVERSE SEQUELAE RESULTED FROM THIS COMPLICATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    SHIN ET AL IN THE JOURNAL FOR VASCULAR SURGERY; LIMITATIONS OF THE OUTBACK LTD RE-ENTRY DEVICE IN FEMOROPOPLITEAL CHRONIC TOTAL OCCLUSIONS, DOI: 10.1016/J.JVS.2010.10.27; REPORT THAT DURING A RETROSPECTIVE REVIEW OF PATIENTS WITH FEMOROPOPLITEAL CTO FROM (B)(6) 2006 TO (B)(6) 2009, THE OUTBACK CATHETER CREATED AN ARTERIOVENOUS FISTULA. NO INTERVENTION WAS PERFORMED AND NO ADVERSE SEQUELAE RESULTED FROM THIS COMPLICATION

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention