BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 2212303 · Received August 15, 2011

    Report

    Report Number
    3005099803-2011-02770
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DISTAL HANDLE AND OUTER SHEATH HAD BEEN FULLY RETRACTED AND THE STENT HAD BEEN FULLY DEPLOYED. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT. IT WAS OBSERVED THROUGH THE CLEAR OUTER SHEATH THAT THE INNER LUMEN HAD FOLDED BACK ON ITSELF. A KINK WAS NOTED IN THE CATHETER AT 30MM DISTAL TO THE GUIDEWIRE ACCESS PORT. SLIGHT RESISTANCE WAS NOTED DURING MOVEMENT OF THE OUTER SHEATH POSSIBLY DUE TO THE INNER LUMEN BEING FOLDED BACK ON ITSELF. NO OTHER ISSUES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED 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 PERFORMANCE OF THIS DEVICE WAS LIKELY LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, 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 BILIARY RX UNCOVERED STENT SYSTEM WAS USED DURING AN ENDOSCOPE RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE AS A RESULT OF A MALIGNANT KLATSKIN TUMOR. THE STRICTURE WAS LOCATED FROM THE BIFURCATION OF THE RIGHT AND LEFT HEPATIC DUCTS INTO THE LIVER. THE PATIENT ANATOMY WAS TORTUOUS AND THE STENOSIS WAS NOTED TO BE "SIGNIFICANT." THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS POSITIONED WITHIN THE PATIENT AT THE DESIRED LOCATION. THE PHYSICIAN BEGAN TO DEPLOY THE STENT. HOWEVER, THE PHYSICIAN WITHDREW THE SHEATH COMPLETELY BUT THE STENT WAS ONLY PARTIALLY DEPLOYED. THE STENT WAS NOT RECONSTRAINED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT ON THE DELIVERY SYSTEM. THE USER NOTED THAT THE DELIVERY CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX UNCOVERED STENT SYSTEM. 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 BILIARY RX UNCOVERED STENT SYSTEM WAS USED DURING AN ENDOSCOPE RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE AS A RESULT OF A MALIGNANT KLATSKIN TUMOR. THE STRICTURE WAS LOCATED FROM THE BIFURCATION OF THE RIGHT AND LEFT HEPATIC DUCTS INTO THE LIVER. THE PATIENT ANATOMY WAS TORTUOUS AND THE STENOSIS WAS NOTED TO BE "SIGNIFICANT." THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS POSITIONED WITHIN THE PATIENT AT THE DESIRED LOCATION. THE PHYSICIAN BEGAN TO DEPLOY THE STENT. HOWEVER, THE PHYSICIAN WITHDREW THE SHEATH COMPLETELY, BUT THE STENT WAS ONLY PARTIALLY DEPLOYED. THE STENT WAS NOT RECONSTRAINED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT ON THE DELIVERY SYSTEM. THE USER NOTED THAT THE DELIVERY CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX UNCOVERED STENT SYSTEM. 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
    1 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570660 0014270308

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR