BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE

    MDR report key: 1933060 · Received December 20, 2010

    Report

    Report Number
    3005099803-2010-05054
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. THE OUTER SHEATH WAS RETRACTED FROM THE DISTAL TIP BY 9 MM. IT WAS VISIBLE THAT A STENT WIRE PERFORATED THE OUTER SHEATH AT APPROXIMATELY 7 MM PROXIMAL TO THE DISTAL END OF THE OUTER SHEATH. THE INNER LUMEN WAS PARTIALLY EXITING THE GUIDEWIRE ACCESS PORT. DURING ANALYSIS WHEN THE DISTAL HANDLE WAS RETRACTED, THE INNER LUMEN EXITED FURTHER THROUGH THE GUIDEWIRE ACCESS PORT AND THE OUTER SHEATH COULD NOT BE RETRACTED. THE SHAFT WAS DISSECTED PROXIMAL TO THE GUIDEWIRE ACCESS PORT AND THE INNER LUMEN AND STENT WERE WITHDRAWN. DURING WITHDRAWAL OF THE STENT (DURING ANALYSIS), THE OUTER SHEATH BECAME KINKED AT SEVERAL LOCATIONS ALONG THE LENGTH OF THE OUTER SHEATH. IT WAS NOTED THAT THE DISTAL AND PROXIMAL STENT WIRES WERE DAMAGED AND THE INNER LUMEN WAS KINKED AT VARIOUS LOCATIONS BETWEEN THE SKIVED AREA AND WHERE IT WAS DISSECTED. 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 WALLSTENT RX BILIARY ENDOPROSTHESES WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A THREE CENTIMETER MALIGNANT TUMOR ON THE MID COMMON BILE DUCT. THE ANATOMY WAS NOT TORTUOUS, NOR DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE THE PHYSICIAN GAINED ACCESS UP THE BILE DUCT WITH A HYDRJAGWIRE AND DID A SPHINCTEROTOMY WITH AN AUTOTOME. THE STENT DEVICE WAS BACKLOAD OVER THE GUIDE WIRE INTO THE BILE DUCT. ONCE THE STENT WAS IN PLACE, THE HANDLE WAS WITHDRAWN TO DEPLOY THE STENT; HOWEVER THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT, AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT OUTSIDE THE PATIENT; HOWEVER THE STENT STILL DID NOT DEPLOY. IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER WALLSTENT RX BILIARY ENDOPROSTHESES. 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 STENT WIRES PERFORATED THE SHEATH. BASED ON THIS INFORMATION, THE EVENT IS NOW DEEMED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00569700 0013345720

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR AUTOTOME| HYDRAJAGWIRE