BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2894848 · Received January 3, 2013

    Report

    Report Number
    3005099803-2012-06357
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    September 27, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD. (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. THE OUTER SHEATH WAS KINKED JUST PROXIMAL TO THE MOUNTED STENT. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THE OUTER SHEATH WAS STRETCHED FOR A DISTANCE OF APPROXIMATELY 175 MM FROM THE HANDLE BREAK. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. IT WAS NOTED THAT THE PROXIMAL END OF THE STAINLESS STEEL SHAFT WAS SLIGHTLY BENT. DURING ANALYSIS IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH TO DEPLOY THE STENT SO THE SHAFT WAS DISSECTED PROXIMAL TO THE STENT AND THE INNER SHAFT AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER SHAFT. NO ISSUES WERE NOTED WITH THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. 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 INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE 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. 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 DUODENAL STENT DEVICE WAS USED DURING A DUODENAL STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE DUODENAL STRICTURE EXTENDED FROM HORIZONTAL PART OF DUODENUM TO THE LIGAMENT OF TREITZ. REPORTEDLY, THE ANATOMY WAS TORTUOUS, AND THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO THE STENT PLACEMENT. DURING THE PROCEDURE, WHEN IT WAS ATTEMPTED TO RELEASE THE STENT, RESISTANCE WAS MET. THE DEVICE WAS REMOVED AND OLIVE OIL WAS INJECTED INTO THE CHANNEL OF ENDOSCOPE AND TO THE STENT. REPORTEDLY, THE STENT WAS ABOUT 30% DEPLOYED AND AFTER THE OLIVE OIL WAS APPLIED, THE STENT WAS RECONSTRAINED. THE DEVICE WAS REINSERTED BUT FAILED TO DEPLOY AGAIN AND THE HANDLE DETACHED. THE DEVICE WAS REMOVED FROM THE PATIENT FULLY CONSTRAINED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO OTHER ISSUES WERE NOTED TO THE DEVICE. 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
    2306 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030 0015232307

    Patients

    Seq Age Sex Outcome Treatment
    1