BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 3003788 · Received March 14, 2013

    Report

    Report Number
    3005099803-2013-01302
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    October 31, 2012
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 5MM. IT WAS NOTED THAT THE INNER LUMEN WAS EXITING AT THE GUIDEWIRE EXIT PORT AND WAS KINKED. DURING A FUNCTIONAL ANALYSIS, WHEN AN ATTEMPT WAS MADE TO RETRACT THE DISTAL HANDLE, A RESTRICTION WAS MET AND THE STENT COULD NOT BE DEPLOYED. THE SHAFT WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS SLEEVE AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. THE INNER LUMEN WAS SLIGHTLY KINKED AT SEVERAL LOCATIONS WHERE THE STENT HAD BEEN MOUNTED AND WAS ALSO KINKED WHERE IT HAD FOLDED BACK ON ITSELF. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A REMOVABLE WALLFLEX BILIARY RX FULLY COVERED STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE BILIARY DUCT OF A PATIENT ON (B)(6) 2012 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A MALIGNANT STRICTURE WITHIN THE BILIARY DUCT. DURING THE PROCEDURE, THE USER WAS UNABLE TO RETRACT THE OUTER SHEATH IN ORDER TO DEPLOY THE STENT. THEREFORE, THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY POST PROCEDURE. BASED ON THE EVALUATION FINDINGS, WHICH INDICATE THAT THE STENT WAS RETURNED PARTIALLY DEPLOYED, THIS IS NOW A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107526 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570480 0015610030

    Patients

    Seq Age Sex Outcome Treatment
    1