BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 4092470 · Received September 16, 2014

    Report

    Report Number
    3005099803-2014-03140
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) STENT FAILED TO EXPAND. (B)(4) STENT DAMAGED. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 PARTIALLY COVERED WALLFLEX BILIARY RX STENT WAS USED IN THE COMMON BILE DUCT DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO PREVENT THE BILE LEAKING INTO THE GALLBLADDER DUE TO DAMAGE OF THE GALLBLADDER WALL. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND A CONTRAST STUDY WAS PERFORMED IN THE BILE DUCT PRIOR TO PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THE STENT PLACING THE DISTAL TIP IN THE PAPILLA SUCCESSFULLY. HOWEVER, THE STENT WIRE LOCATED IN THE DUODENUM WAS BENT AND FAILED TO FULLY EXPAND. NO INTERVENTION WAS DONE TO FULLY EXPAND THE STENT AND WAS LEFT IN IMPLANTED SINCE BILE DRAINED FROM THE LUMEN WITHOUT ISSUES. 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
    573440 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00580110 16971610

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR