BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 1944857 · Received January 3, 2011

    Report

    Report Number
    3005099803-2010-05411
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX UNCOVERED BILIARY RX STENT WAS USED DURING AN ERCP ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO DEPLOY THE STENT, THE PROXIMAL PART OF THE HANDLE BROKE; THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE AND COMPLETE THE PROCEDURE WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570630 13499626

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR