BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 3925617 · Received July 10, 2014

    Report

    Report Number
    3005099803-2014-02486
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFO: THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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 STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILIARY METAL STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE STENT WAS DEPLOYED IN THE CORRECT LOCATION WITHOUT ANY ISSUE DURING THE INITIAL PLACEMENT. ON (B)(6), 2014, UNDER ESOPHAGOGASTRODUODENOSCOPY, THE STENT WAS NOTED TO HAVE MIGRATED TO THE SMALL BOWEL. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT WITH AN ENTEROSCOPE VIA THE MOUTH AND THROUGH THE PATIENTS' COLOSTOMY STOMA, BUT WAS UNSUCCESSFUL. THE PHYSICIAN LEFT THE STENT IMPLANTED AS THE PATIENT IS ASYMPTOMATIC. 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 GOOD. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405111 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK475

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention