BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY

    MDR report key: 8805100 · Received July 18, 2019

    Report

    Report Number
    3005099803-2019-03506
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 22, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729759324
    PMA / PMN Number
    K140630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2019-03505 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT TWO WALLFLEX BILIARY RX PARTIALLY COVERED STENTS WERE TO BE USED TO TREAT A PANCREATIC HEAD MASS WHICH BLOCKED THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH WALLFLEX BILARY STENTS WERE ABLE TO BE DEPLOYED. HOWEVER, AFTER THE DELIVERY SYSTEMS WERE REMOVED, THE STENTS MIGRATED OUT OF THE COMMON BILE DUCT. BOTH STENTS WERE REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598258 WALLFLEX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00570730 08714729759324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention