BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC BILIARY

    MDR report key: 17338941 · Received July 17, 2023

    Report

    Report Number
    3005099803-2023-03862
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 29, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729896968
    PMA / PMN Number
    K171809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. BLOCK H11: BLOCKS B5 HAS BEEN CORRECTED.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 29, 2023, THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED TO TREAT GASTRIC OUTLET OBSTRUCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH FLUOROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT FULLY DEPLOYED INSIDE THE SCOPE. NO ADDITIONAL STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE STENT WAS INTENDED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO). HOWEVER, PER THE EPIC BILIARY ENDOSCOPIC STENT SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INTENDED TO TREAT PATIENTS WITH BILIARY STRICTURES CREATED BY MALIGNANT NEOPLASMS AND IS TO BE DELIVERED ENDOSCOPICALLY. THE DEVICE IS NOT INDICATED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE PANCREAS TO TREAT GASTRIC OUTLET OBSTRUCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH FLUOROSCOPY PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT FULLY DEPLOYED INSIDE THE SCOPE. NO ADDITIONAL STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE STENT WAS INTENDED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO). HOWEVER, PER THE EPIC BILIARY ENDOSCOPIC STENT SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INTENDED TO TREAT PATIENTS WITH BILIARY STRICTURES CREATED BY MALIGNANT NEOPLASMS AND IS TO BE DELIVERED ENDOSCOPICALLY. THE DEVICE IS NOT INDICATED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715735 EPIC BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00572340 0030236227 08714729896968

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown