BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1954710 · Received January 10, 2011

    Report

    Report Number
    3005099803-2011-00034
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Report Date
    December 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE STENT DEPLOYED AND NOT RETURNED. THE CATHETER DELIVERY SYSTEM WAS SPLIT INTO TWO SECTIONS, WITH THE OUTER SHEATH RETRACTED FROM THE DISTAL TIP. THE INNER LUMEN OF THE DEVICE HAD SEPARATED INTO TO PARTS APPROXIMATELY 380MM DISTAL FROM THE HANDLE, AND IT WAS KINKED AT 90MM PROXIMAL FROM THE DISTAL TIP. THE BLUE OUTER SHEATH WAS ALSO ACCORDIONED AND TORN AT 168MM DISTAL FROM THE HANDLE. THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH THE COMPLAINT EVENT. THE MOST PROBABLE ROOT CAUSE IS BEING LABELED AS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONOSCOPY PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE BLUE PLASTIC PORTION OF THE DELIVERY SYSTEM BROKE HALFWAY THROUGH DEPLOYMENT. DESPITE THIS DAMAGE, THE PHYSICIAN WAS STILL ABLE TO DEPLOY THE STENT WITHOUT ANY COMPLICATIONS. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONOSCOPY PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE BLUE PLASTIC PORTION OF THE DELIVERY SYSTEM BROKE HALFWAY THROUGH DEPLOYMENT. DESPITE THIS DAMAGE, THE PHYSICIAN WAS STILL ABLE TO DEPLOY THE STENT WITHOUT ANY COMPLICATIONS. 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 FINE.

    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 13803698

    Patients

    Seq Age Sex Outcome Treatment
    1