BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2850880 · Received November 29, 2012

    Report

    Report Number
    3005099803-2012-05610
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    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

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN FULLY DEPLOYED FROM THE DEVICE. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THE OUTER SHEATH WAS ACCORDIONED AT ITS PROXIMAL END. DURING A FUNCTIONAL ANALYSIS, IT WAS POSSIBLE TO MOVE THE OUTER SHEATH ALONG THE SHAFT WITHOUT ANY ISSUES BEING NOTED. THE SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH AND THE DISTAL END OF THE INNER LUMEN WAS WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE INNER LUMEN THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE OUTER SHEATH WAS DISSECTED LONGITUDINALLY AND NO ISSUES WERE NOTED. 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 WALLFLEX ENTERAL COLONIC STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE SIGMOID COLON OF A PATIENT ON (B)(6) 2012 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STRICTURE WITHIN THE SIGMOID COLON. THE STRICTURE WAS REPORTED TO BE APPROXIMATELY 4-5 CM IN LENGTH. DURING THE PROCEDURE, THE PHYSICIAN BEGAN TO PULL ON THE HANDLE OF THE DEVICE IN AN ATTEMPT TO DEPLOY THE STENT. HOWEVER, THE WHITE HANDLE DETACHED FROM THE OUTER SHEATH. REPORTEDLY, THE PHYSICIAN DID NOT USE FORCE TO PULL THE HANDLE. THE PORTION OF THE STENT THAT WAS DEPLOYED COULD NOT BE RECONSTRAINED. THEREFORE, THE PARTIALLY DEPLOYED STENT WAS REMOVED WITH THE ENDOSCOPE. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN DID NOT HAVE ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD" POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS ATTEMPTED TO BE IMPLANTED WITHIN THE SIGMOID COLON OF A PATIENT ON (B)(6) 2012 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR TREATMENT OF A STRICTURE WITHIN THE SIGMOID COLON. THE STRICTURE WAS REPORTED TO BE APPROXIMATELY 4-5 CM IN LENGTH. DURING THE PROCEDURE, THE PHYSICIAN BEGAN TO PULL ON THE HANDLE OF THE DEVICE IN AN ATTEMPT TO DEPLOY THE STENT. HOWEVER, THE WHITE HANDLE DETACHED FROM THE OUTER SHEATH. REPORTEDLY, THE PHYSICIAN DID NOT USE FORCE TO PULL THE HANDLE. THE PORTION OF THE STENT THAT WAS DEPLOYED COULD NOT BE RECONSTRAINED. THEREFORE, THE PARTIALLY DEPLOYED STENT WAS REMOVED WITH THE ENDOSCOPE. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN DID NOT HAVE ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565120 15359685

    Patients

    Seq Age Sex Outcome Treatment
    1