BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 1171198 · Received September 22, 2008

    Report

    Report Number
    9616099-2008-02292
    Event Type
    Injury
    Date Received
    September 22, 2008
    Report Date
    August 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K060877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING, HOWEVER, THE ENGINEERING EVAL IS NOT YET COMPLETE. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE STENT DID NOT COME OUT OF BALLOON. THE STENT MIGRATED TO RIGHT ILIAC AND NEEDED TO BE TREATED. A NEW STENT WAS USED TO FINISH THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 13278132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention