BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3121679 · Received May 21, 2013

    Report

    Report Number
    3005099803-2013-04179
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT EVENT DATE WAS NOT PROVIDED, THE EVENT WAS REPORTED TO HAVE OCCURRED IN (B)(6) 2013. (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DEVICE WAS RECEIVED IN THREE SECTIONS. THE STAINLESS STEEL HANDLE HAD DETACHED FROM THE DEVICE AND A SECTION OF THE INNER LUMEN FROM WITHIN THE STAINLESS STEEL HANDLE HAD SEPARATED. THE DISTAL HANDLE THAT HAD DETACHED FROM THE OUTER SHEATH WAS NOT RETURNED. THE OUTER SHEATH WAS ACCORDIONED AT ITS PROXIMAL END, WHERE THE DISTAL HANDLE HAD DETACHED. THE TIP WAS WITHDRAWN INTO THE OUTER SHEATH AND THE OUTER SHEATH WAS KINKED PROXIMAL TO THE MOUNTED STENT. IT WAS NOTED THAT THE SHAFT WAS BENDING WHERE THE STENT WAS MOUNTED. FUNCTIONALLY, IT WAS NOT POSSIBLE TO DEPLOY THE STENT IN ITS RETURNED CONDITION. THEREFORE, THE SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH. THE OUTER SHEATH WAS DISSECTED LONGITUDINALLY AND IT WAS NOTED THAT SOME OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH. 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 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #¿S 3005099803-2013-04179 AND 3005099803-2013-03907. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX ENTERAL COLONIC STENTS WERE ATTEMPTED TO BE IMPLANTED WITHIN THE COLON OF A PATIENT DURING A COLONOSCOPY PROCEDURE WITH STENT PLACEMENT IN (B)(6) 2013 (EXACT PROCEDURE DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT WAS DIAGNOSED WITH COLON CANCER. THE INDICATION FOR THE STENT PLACEMENT WAS FOR PALLIATIVE TREATMENT OF A STENOSIS WITHIN THE RECTO-SIGMOID COLON. THE PATIENT¿S ANATOMY WAS REPORTED TO BE TORTUOUS. NO VISIBLE ISSUES WERE NOTED TO THE DEVICES. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY TWO STENTS WITHIN THE PATIENT¿S COLON. HOWEVER, BOTH STENTS COULD NOT BE DEPLOYED. THE STENTS WERE REMOVED FROM THE PATIENT FULLY CONSTRAINED ON THEIR DELIVERY SYSTEMS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. BASED ON THE EVALUATION FINDINGS, WHICH INDICATE THAT SOME OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH, THIS IS NOW A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225037 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565060 15289509

    Patients

    Seq Age Sex Outcome Treatment
    1