BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1983763 · Received February 10, 2011

    Report

    Report Number
    3005099803-2011-00225
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE STENT FULLY MOUNTED. THE CLEAR OUTER SHEATH WAS KINKED IN A COUPLE LOCATIONS, AND THE BLUE OUTER SHEATH WAS TORN, WHICH MADE THE INNER LUMEN VISIBLE. DURING A FUNCTIONAL TEST, WHEN THE HANDLE WAS RETRACTED, THE INNER LUMEN EXITED THROUGH THE DAMAGED AREA OF THE BLUE OUTER SHEATH, PREVENTING THE STENT FROM BEING DEPLOYED. THE DEVICE WAS DISSECTED AND THE INNER LUMEN WAS FOUND TO BE KINKED AT SEVERAL LOCATIONS. ADDITIONALLY, THE CENTER PORTION OF THE STENT WAS ALSO KINKED (IN A LOCATION THAT COINCIDES WITH THE KINKS OF THE CLEAR OUTER SHEATH). THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT EVENT. THE MOST PROBABLE ROOT CAUSE IS BEING LABELED AS 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 NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY ENDOPROSTHESIS WAS USED DURING A STENTING PROCEDURE WITHIN THE BILIARY DUCT ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO DEPLOY THE STENT, THE CATHETER OF THE DELIVERY SYSTEM KINKED AND THE STENT COULD NOT BE DEPLOYED. WHEN EXTRA FORCE WAS APPLIED, THE HANDLE OF THE DELIVERY SYSTEM BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER WALLSTENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PHYSICIAN NOTED THAT THE ANATOMY WAS NOT TORTUOUS, AND THE STRICTURE WAS NOT PREDILATED. 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 WALLSTENT BILIARY ENDOPROSTHESIS WAS USED DURING A STENTING PROCEDURE WITHIN THE BILIARY DUCT ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO DEPLOY THE STENT, THE CATHETER OF THE DELIVERY SYSTEM KINKED AND THE STENT COULD NOT BE DEPLOYED. WHEN EXTRA FORCE WAS APPLIED, THE HANDLE OF THE DELIVERY SYSTEM BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER WALLSTENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PHYSICIAN NOTED THAT THE ANATOMY WAS NOT TORTUOUS, AND THE STRICTURE WAS NOT PREDILATED. 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
    1 WALLSTENT BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965430500 13581039

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR