BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2970363 · Received February 20, 2013

    Report

    Report Number
    3005099803-2013-00826
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS OVER 18 YEARS OLD. (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. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THE OUTER SHEATH WAS STRETCHED FOR A DISTANCE OF 115MM FROM ITS PROXIMAL END. THE OUTER SHEATH WAS KINKED AT BOTH THE PROXIMAL AND DISTAL END OF THE MOUNTED STENT. A BEND WAS ALSO NOTED IN THE STAINLESS STEEL HANDLE. DURING ANALYSIS AN ATTEMPT WAS MADE TO RETRACT THE OUTER SHEATH AND DEPLOY THE STENT, HOWEVER, RESTRICTION WAS MET. 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SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH.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. NO ISSUES WERE NOTED IN MOVEMENT OF THE OUTER SHEATH OF THE PROXIMAL END OF THE SHAFT AFTER IT HAD BEEN DISSECTED. 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. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT DEVICE WAS USED DURING A COLONIC STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS PALLIATIVE TREATMENT FOR A STRICTURE AT THE SPLENIC FLEXURE. THE PATIENT ANATOMY WAS REPORTED TO BE TORTUOUS. DURING THE PROCEDURE, A GUIDEWIRE WAS ADVANCED TO THE INTENDED POSITION AND THEN THE WALLFLEX WAS ADVANCED TO THE INTENDED POSITION. IN ATTEMPT TO DEPLOY THE STENT, THE OUTER SHEATH COULD NOT BE PULLED. THE STENT COULD NOT BE DEPLOYED AND THE DISTAL HANDLE BROKE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIZE WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH FOUND PART OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73256 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565120 15390603

    Patients

    Seq Age Sex Outcome Treatment
    1