BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 2041870 · Received April 6, 2011

    Report

    Report Number
    3005099803-2011-01133
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE OUTER SHEATH WAS CLOSED TO THE TIP ON THE DEVICE INDICATING THAT THE OUTER SHEATH HAD BEEN CLOSED TO THE TIP PRIOR TO WITHDRAWAL OF THE STENT SYSTEM AS PER THE DIRECTIONS FOR USE (DFU). THE CLEAR OUTER SHEATH WAS FOUND TO BE KINKED. NO OTHER ISSUES WERE NOTED TO THE DEVICE. ONLY THE STENT DELIVERY SYSTEM WAS RETURNED AS THE STENT WAS IMPLANTED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THEREFORE, THE KINKED OUTER SHEATH IS LIKELY DUE TO PROCEDURAL/ANATOMICAL FACTORS AND THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE STENT HAS BEEN IMPLANTED; HOWEVER THE DELIVERY SYSTEM 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED WITHIN THE BILE DUCT OF PATIENT WITH A BILIARY LESION ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST STENT PLACEMENT, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DELIVERY CATHETER. IT WAS REPORTED THAT THE STENT WAS FULLY EXPANDED POST DEPLOYMENT. DESPITE THE DIFFICULTY, THE DELIVERY CATHETER WAS ABLE TO BE REMOVED, AND THE STENT REMAINS WITHIN THE SAME POSITION INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT EXPERIENCED ABDOMINAL PAIN FOR 48 HOURS POST PROCEDURE, WHICH THE PHYSICIAN ATTRIBUTED TO THE PROCEDURE. NO TREATMENT OR INTERVENTION WAS PERFORMED, AS THE PATIENT'S PAIN WAS REPORTED TO BE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED WITHIN THE BILE DUCT OF PATIENT WITH A BILIARY LESION ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, POST STENT PLACEMENT, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DELIVERY CATHETER. IT WAS REPORTED THAT THE STENT WAS FULLY EXPANDED POST DEPLOYMENT. DESPITE THE DIFFICULTY, THE DELIVERY CATHETER WAS ABLE TO BE REMOVED, AND THE STENT REMAINS WITHIN THE SAME POSITION INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT EXPERIENCED ABDOMINAL PAIN FOR 48 HOURS POST PROCEDURE, WHICH THE PHYSICIAN ATTRIBUTED TO THE PROCEDURE. NO TREATMENT OR INTERVENTION WAS PERFORMED, AS THE PATIENT¿S PAIN WAS REPORTED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570620 0013569280

    Patients

    Seq Age Sex Outcome Treatment
    1