BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 3822468 · Received May 21, 2014

    Report

    Report Number
    3005099803-2014-02008
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REPORT OF INNER SHAFT DETACHED. THE STENT OF THE RETURNED DEVICE WAS DEPLOYED. THE STENT ITSELF WAS NOT RETURNED TO THE CIS FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE INNER LUMEN WAS BROKEN 250MM PROXIMAL TO THE TIP, WHICH IS AT THE SKIVED AREA OF THE INNER. IT WAS ALSO NOTED THAT THE DETACHED SECTION OF INNER WAS SEVERELY KINKED. THE INNER MEMBER JACKET WAS ALSO KINKED 11MM DISTAL TO ITS DISTAL END. THE DISTAL END OF THE INNER THAT WAS REMAINING INSIDE THE OUTER SHEATH WAS FOUND TO BE KINKED AND BENT BACK ON ITSELF. THE DISTAL HANDLE WAS FULLY RETRACTED AND A SEVERE BEND WAS EVIDENT AT THE LIMIT MARKER. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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.  THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS 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 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 WALLFLEX BILIARY PARTIALLY COVERED STENT WAS IMPLANTED IN DUCTUS CHOLEDOCHUS DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, THE STENT WAS DIFFICULT TO RELEASE. IT WAS ALSO REPORTED THAT THE HANDLE DETACH FROM THE OUTER SHEATH AND THE DELIVERY CATHETER WAS RIPPED. THE STENT WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303746 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570730 0016320091

    Patients

    Seq Age Sex Outcome Treatment
    1