BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 2955630 · Received February 11, 2013

    Report

    Report Number
    3005099803-2013-00706
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. (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 OUTER SHEATH HAD BEEN FULLY RETRACTED AND THE STENT HAD BEEN FULLY DEPLOYED FROM THE DEVICE AND WAS NOT RETURNED. THE DEVICE WAS RETURNED FOR ANALYSIS IN TWO SECTIONS, AS THE INNER SHAFT HAD DETACHED AT THE SKIVED AREA OF THE INNER SHAFT. IT WAS NOTED THAT THE INNER SHAFT WAS KINKED AND TWISTED IN THIS AREA. NO ISSUES WERE NOTED WITH THE MOVEMENT OF THE OUTER SHEATH DISTALLY OR PROXIMALLY. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. 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 SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED BILIARY STENT SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A BILIARY STRICTURE. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED AT THE DESIRED LOCATION. THE NURSE NOTED THAT THE STENT WAS "MORE DIFFICULT TO DEPLOY THAN NORMAL." UPON WITHDRAWL OF THE STENT DELIVERY SYSTEM, THE INNER CATHETER DETACHED. THE PHYSICIAN WAS ABLE TO SECURE THE INNER CATHETER WITHIN THE ENDOSCOPE BY USING THE BRIDGE OF THE SCOPE. THE INNER CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHIN THE ENDOSCOPE. THE STENT WAS LEFT IMPLANTED AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT 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 PARTIALLY COVERED BILIARY STENT SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A BILIARY STRICTURE. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS. DURING THE PROCEDURE, THE STENT WAS DEPLOYED AT THE DESIRED LOCATION. THE NURSE NOTED THAT THE STENT WAS "MORE DIFFICULT TO DEPLOY THAN NORMAL." UPON WITHDRAWAL OF THE STENT DELIVERY SYSTEM, THE INNER CATHETER DETACHED. THE PHYSICIAN WAS ABLE TO SECURE THE INNER CATHETER WITHIN THE ENDOSCOPE BY USING THE BRIDGE OF THE SCOPE. THE INNER CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHIN THE ENDOSCOPE. THE STENT WAS LEFT IMPLANTED AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59925 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570740 0015179706

    Patients

    Seq Age Sex Outcome Treatment
    1