BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 2001517 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00527
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 WAS FULLY MOUNTED. THE BLUE OUTER SHEATH WAS STRETCHED AND KINKED. 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. DURING ANALYSIS IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH BY HAND SO THE SHAFT WAS DISSECTED PROXIMAL TO THE STENT AND THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. THERE WAS NO ISSUE IN THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. 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.

    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 HAD A SEVEN CENTIMETER MALIGNANT TUMOR, COMMENCING FIFTEEN CENTIMETER FROM THE RECTO-SIGMOID JUNCTION. THE ANATOMY WAS RELATIVELY TORTUOUS. DURING THE PROCEDURE, THE STENT SYSTEM WAS INTRODUCED THROUGH THE COLONOSCOPE INTO THE PATIENT. AS THE NURSE STARTED TO DEPLOY THE STENT, THE DEPLOYMENT HANDLE DETACHED AND THE STENT COULD NO LONGER BE DEPLOYED. IT WAS REPORTED THAT THE HANDLE " JUST SLID UP AND DOWN BUT DIDN'T FEEL CONNECTED TO THE STENT AND DIDN'T CONTINUE TO DEPLOY THE STENT". THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    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 HAD A SEVEN CENTIMETER MALIGNANT TUMOR, COMMENCING FIFTEEN CENTIMETER FROM THE RECTO-SIGMOID JUNCTION. THE ANATOMY WAS RELATIVELY TORTUOUS. DURING THE PROCEDURE, THE STENT SYSTEM WAS INTRODUCED THROUGH THE COLONOSCOPE INTO THE PATIENT. AS THE NURSE STARTED TO DEPLOY THE STENT, THE DEPLOYMENT HANDLE DETACHED AND THE STENT COULD NO LONGER BE DEPLOYED. IT WAS REPORTED THAT THE HANDLE " JUST SLID UP AND DOWN BUT DIDN'T FEEL CONNECTED TO THE STENT AND DIDN'T CONTINUE TO DEPLOY THE STENT". THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ENTERAL COLONIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    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 M00565060 14012639

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR