BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1983757 · Received February 10, 2011

    Report

    Report Number
    3005099803-2011-00224
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. THE BLUE OUTER SHEATH WAS SEPARATED FROM THE DISTAL HANDLE. THE PROXIMAL END OF THE INNER MEMBER JACKET WAS SEPARATED FROM THE DISTAL END OF THE STAINLESS STEEL SHAFT; HOWEVER, THE INNER LUMEN WAS STILL ATTACHED. DURING ANALYSIS IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH BY HAND. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER LUMEN. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. IT SHOULD BE NOTED THAT, THE DFU / PRODUCT LABEL STATES "NOTE: THE FULLY EXPANDED STENT LENGTH SHOULD BE AT LEAST 4 CM LONGER THAN THE LENGTH OF THE STRICTURE". HOWEVER, THE COMPLAINT STATES THAT THE 9 CM STENT WAS INTENDED TO BE USED TO TREAT A 6 CM LESION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONIC STENTING PROCEDURE ON (B)(6), 2011.ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A SIX CENTIMETER STRICTURE AT THE SIGMOID COLON AS A RESULT OF COLON CANCER. DURING THE PROCEDURE, THE METAL HANDLE TUBE DETACHED FROM THE CATHETER. AS A RESULT OF THE HANDLE BREAK, THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565050 13789016

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR