BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3121694 · Received May 21, 2013

    Report

    Report Number
    3005099803-2013-03907
    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 FOUND THAT THE STENT WAS FULLY MOUNTED ONTO THE DEVICE. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THE OUTER SHEATH WAS BROKEN AT 100MM DISTAL TO ITS PROXIMAL END. THE SHAFT WAS KINKED PROXIMAL TO THE MOUNTED STENT. DURING A FUNCTIONAL ANALYSIS, AN ATTEMPT COULD NOT BE MADE TO RETRACT THE OUTER SHEATH AND DEPLOY THE STENT DUE TO THE CONDITION OF THE RETURNED DEVICE. THE SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE INNER LUMEN OR DEPLOYED STENT THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT REPORTED. 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. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 INDICATES THAT THE OUTER SHEATH WAS BROKEN AND 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
    225041 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565060 15289509

    Patients

    Seq Age Sex Outcome Treatment
    1