BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 2013449 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00773
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    November 29, 2010
    Report Date
    February 17, 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 STENT WAS FULLY MOUNTED. THE DISTAL HANDLE WAS RETRACTED PROXIMAL TO THE THRESHOLD MARKER ON THE DEPLOYMENT HANDLE. THE BLUE OUTER SHEATH WAS BROKEN AT THE BRAIDED SECTION OF THE CLEAR OUTER SHEATH. THE DISTAL CLEAR OUTER SHEATH WAS ALSO DETACHED. IT IS LIKELY THAT EXCESSIVE FORCE APPLIED TO THE DEVICE DURING THE PROCEDURE CAUSED THE OUTER SHEATH TO BREAK. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING STENT PLACEMENT PROCEDURE WITHIN THE BILE DUCT OF A PATIENT WITH BILIARY CANCER ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A STENOSIS AS A RESULT OF A HEPATIC DUCT TUMOR. DURING THE PROCEDURE THE STENT WAS UNABLE TO BE DEPLOYED, IT WAS REPORTED THAT THE DELIVERY SYSTEM DID NOT WORK PROPERLY. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX UNCOVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE OUTER SHEATH WAS BROKEN AND DETACHED. THEREFORE, THIS EVENT IS NOW CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570640 13757063

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR