BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1081531 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01288
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, THE STENT FAILED TO DEPLOY. THE LESION WAS LOCATED IN THE COMMON BILE DUCT (CBD). THE RX WALLSTENT PERMALUME 10MM X 80MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE PHYSICIAN RETRACTED THE DELIVERY CATHETER, HOWEVER, THE STENT "DID NOT COME OFF THE CATHETER. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569720 0009608149

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR