BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 2994265 · Received March 8, 2013

    Report

    Report Number
    3005099803-2013-01513
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    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. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEVICE. DURING ANALYSIS WHEN THE DISTAL HANDLE WAS RETRACTED, THE INNER SHAFT EXITED THROUGH THE GUIDEWIRE ACCESS PORT AND THE OUTER SHEATH COULD NOT BE RETRACTED. THE SHAFT WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS PORT AND THE INNER SHAFT AND STENT WERE WITHDRAWN. THE COMPRESSED AREA OF THE INNER SHAFT WAS KINKED PROXIMAL TO THE YELLOW INNER JACKET FROM WHERE IT HAD EXITED THROUGH THE GUIDEWIRE ACCESS PORT. NO ISSUES WERE NOTED WITH THE DEPLOYED STENT. NO ISSUES WERE NOTED WITH THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. THE INVESTIGATION CONCLUDED THAT THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX RX BILIARY PARTIALLY COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT A NEOPLASTIC STRICTURE WITHIN THE BILE DUCT. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. DURING THE PROCEDURE WITH THIS DEVICE, THE STENT WAS PARTIALLY DEPLOYED AND COULD NOT BE FULLY DEPLOYED DO TO THE INTRODUCOR BEING BENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX RX BILIARY PARTIALLY COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT A NEOPLASTIC STRICTURE WITHIN THE BILE DUCT. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. DURING THE PROCEDURE WITH THIS DEVICE, THE STENT WAS PARTIALLY DEPLOYED AND COULD NOT BE FULLY DEPLOYED DO TO THE INTRODUCER BEING BENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100171 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570740 15607300

    Patients

    Seq Age Sex Outcome Treatment
    1