BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1843882 · Received September 24, 2010

    Report

    Report Number
    3005099803-2010-04071
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K000308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE DEPLOYER (HANDLE) BREAK. 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 THE OUTER SHEATH WAS RETRACTED FROM THE DISTAL TIP BY 2MM. ADDITIONALLY, THE T-BAR CONNECTOR WAS DETACHED FROM THE OUTER SHEATH, WHICH IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THERE WAS EVIDENCE OF GLUE PRESENT AT THE T-BAR CONNECTOR, INDICATING THAT IT HAD BEEN APPLIED DURING MANUFACTURING (AS IS REQUIRED). DURING A FUNCTIONAL ANALYSIS, SOME RESISTANCE WAS FELT WHEN AN ATTEMPT WAS MADE TO RETRACT THE OUTER SHEATH; HOWEVER, IT WAS POSSIBLE TO FULLY DEPLOY THE STENT. NO ISSUES WERE NOTED WITH THE INNER LUMEN OR WITH THE DEPLOYED STENT. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE HAS BEEN LABELED AS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. 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 COVERED BILIARY ENDOPROSTHESIS WAS USED DURING A BILIARY STENTING PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, THE STENT WAS INSERTED OVER THE GUIDEWIRE THROUGH THE WORKING CHANNEL OF THE DUODENOSCOPE INTO THE BILIARY TRACT. THERE WAS NO PROBLEM PASSING THE STRICTURE. DURING THE INITIAL ATTEMPT TO DEPLOY THE STENT, THE HANDLE OF THE DELIVERY SYSTEM BROKE AND SEPARATED FROM THE OUTER SHEATH. THE COMPLAINANT NOTED THAT THE STENT WAS NOT PARTIALLY DEPLOYED, AND THE STENT WIRES DID NOT PERFORATE THE OUTER SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND ANOTHER WALLSTENT WAS USED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT COVERED BILIARY ENDOPROSTHESIS WAS USED DURING A BILIARY STENTING PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, THE STENT WAS INSERTED OVER THE GUIDEWIRE THROUGH THE WORKING CHANNEL OF THE DUODENOSCOPE INTO THE BILIARY TRACT. THERE WAS NO PROBLEM PASSING THE STRICTURE. DURING THE INITIAL ATTEMPT TO DEPLOY THE STENT, THE HANDLE OF THE DELIVERY SYSTEM BROKE AND SEPARATED FROM THE OUTER SHEATH. THE COMPLAINANT NOTED THAT THE STENT WAS NOT PARTIALLY DEPLOYED, AND THE STENT WIRES DID NOT PERFORATE THE OUTER SHEATH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND ANOTHER WALLSTENT WAS USED 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
    1 WALLSTENT BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965431200 13002804

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR DUODENOSCOPE