BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 3003977 · Received March 14, 2013

    Report

    Report Number
    3005099803-2013-01196
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    November 26, 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 12MM. IT WAS NOTED THAT THE INNER LUMEN WAS EXITING AT THE GUIDEWIRE EXIT PORT AND WAS KINKED. DURING A FUNCTIONAL ANALYSIS, IT WAS NOT POSSIBLE TO RECONSTRAIN THE STENT. FURTHERMORE, WHEN THE DISTAL HANDLE WAS RETRACTED IN ORDER TO FULLY DEPLOY THE STENT, THE OUTER SHEATH DID NOT RETRACT (IN ORDER TO DEPLOY THE STENT) AND THE INNER LUMEN EXITED FURTHER THROUGH THE GUIDEWIRE EXIT PORT. THE SHAFT WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS SLEEVE AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH.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 KINKED PROXIMAL TO THE INNER MEMBER JACKET, 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 PATIENT ON (B)(6) 2012, DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED APPROXIMATELY 1 CM BUT COULD NOT BE DEPLOYED ANY FURTHER. THEREFORE, THE STENT WAS FULLY RECONSTRAINED BACK ONTO THE DELIVERY SYSTEM AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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
    107565 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570490 14122423

    Patients

    Seq Age Sex Outcome Treatment
    1