BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 2860880 · Received December 6, 2012

    Report

    Report Number
    3005099803-2012-05707
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    September 5, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) FOR THE EVALUATION FINDINGS OF SHEATH DETACHED. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN FULLY DEPLOYED FROM THE DEVICE AND WAS NOT RETURNED. A 0.035 INCH GUIDEWIRE WAS RETURNED INSERTED THROUGH THE DEVICE AND NO ISSUES WERE NOTED WITH THE GUIDEWIRE. IT WAS NOTED THAT THE OUTER SHEATH WAS FULLY RETRACTED AND WAS DETACHED AT 6 MM DISTAL TO THE DISTAL END OF THE DISTAL HANDLE. IT WAS NOTED THAT THE HUB HAD BEEN CUT FROM THE STAINLESS STEEL SHAFT AND WAS SEVERELY DAMAGED. DURING A FUNCTIONAL ANALYSIS, IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH. THE SHAFT WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS SLEEVE, AND THE DISTAL END OF THE INNER SHAFT WAS WITHDRAWN FROM THE OUTER SHEATH. THE COMPRESSED AREA OF THE INNER SHAFT WAS KINKED AND FOLDED BACK ON ITSELF PROXIMAL TO THE YELLOW INNER JACKET. NO ISSUES WERE NOTED IN MOVEMENT OF THE OUTER SHEATH OF THE PROXIMAL END OF THE SHAFT AFTER THE SHAFT HAD BEEN DISSECTED. 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 COVERED STENT WAS IMPLANTED WITHIN THE BILIARY TREE 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 CHRONIC PANCREATITIS. THE PATIENT'S ANATOMY WAS REPORTED TO NOT BE TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO THIS PROCEDURE. DURING THE PROCEDURE, AS THE STENT WAS BEING DEPLOYED, IT WAS REPORTED THAT THE OUTER SHEATH WOULD NOT RETRACT IN ORDER TO RELEASE THE PROXIMAL END OF THE STENT. NO VISIBLE ISSUES WERE NOTED TO THE DELIVERY SYSTEM. THE PHYSICIAN HAD TO CUT "CERTAIN PARTS" OF THE DELIVERY SYSTEM IN ORDER TO RELEASE THE STENT. SUBSEQUENTLY, THE STENT WAS ABLE TO BE DEPLOYED AND THE PROCEDURE WAS COMPLETED WITH THIS 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 FOUND THE OUTER SHEATH TO BE DETACHED 6 MM FROM THE DISTAL HANDLE, THIS IS NOW A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570480 15393767

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR