BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM

    MDR report key: 1902028 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04653
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 26, 2010
    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

    PATIENT REPORTED TO BE OVER 18 YEARS OF AGE. THE RETURNED DEVICE PRESENTED WITH THE STENT FULLY MOUNTED ON THE DELIVERY SYSTEM. THERE WAS A CURVE NOTED AT THE DISTAL END OF THE DEVICE. THE OUTER SHEATH WAS SLIGHTLY COMPRESSED IN ONE LOCATION, AND IT HAD BEEN RETRACTED BY 7MM FROM THE TIP. THE DISTAL HANDLE HAD DETACHED AND SEPARATED FROM THE OUTER SHEATH. FUNCTIONALLY, WHEN THE HANDLE WAS ACTUATED, IT FAILED TO RETRACT THE OUTER SHEATH; THE STENT COULD NOT DEPLOY. THE SHAFT WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS PORT AND NO ISSUES WERE FOUND WITH EITHER THE INNER LUMEN OR STENT. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT EVENT THAT THE STENT COULD NOT DEPLOY; HOWEVER, THE HANDLE WAS ALSO FOUND TO BE BROKEN. THE MOST PROBABLE ROOT CAUSE IS LABELED AS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE BILE DUCT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO DEPLOY THE STENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND COULD NOT DEPLOY THE STENT. THE ANATOMY WAS NOTED TO BE MODERATELY TORTUOUS, AND THE STRICTURE WAS NOT PREDILATED. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE WITHOUT ISSUE AND USE A DIFFERENT DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS- THE HANDLE BROKE AND DETACHED FROM THE OUTER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00580110 0013156810

    Patients

    Seq Age Sex Outcome Treatment
    1