BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ BILIARY RX STENT SYSTEM

    MDR report key: 5131979 · Received October 7, 2015

    Report

    Report Number
    3005099803-2015-02787
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K140630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX STENT WAS IMPLANTED TO TREAT A 3CM MALIGNANT DISTAL LESION IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE WALLFLEX BILIARY RX STENT WAS FULLY DEPLOYED IN THE COMMON BILE DUCT. THE PHYSICIAN NOTED THAT UPON REMOVING BOTH THE GUIDEWIRE AND THE STENT DELIVERY SYSTEM THAT IT HAD APPEARED AS THOUGH THE RETRIEVAL LOOPS IN THE DUODENUM WERE NOT COMPLETELY FLARED. THE WALLFLEX BILIARY RX STENT WAS REMOVED FROM THE PATIENT WITH RAT TOOTH FORCEPS DURING THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX STENT. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662905 WALLFLEX¿ BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570520 18144304

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention