BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1994037 · Received February 16, 2011

    Report

    Report Number
    3005099803-2011-00302
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), NO CODE AVAILABLE (THERAPY/NON-SURGICAL TREATMENT, ADDITIONAL). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED; 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 FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00301, 3005099803-2011-00303, AND 3005099803-2011-00304 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR 7FR X 5CM FLEXIMA BILIARY STENT SYSTEMS WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF (B)(6) FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE PROCEDURE, THE FOUR 7FR X 5CM FLEXIMA BILIARY STENT SYSTEM GUIDE CATHETER BROKE INTO MULTIPLE PIECES AS THEY WERE RETRACTED FOR STENT DEPLOYMENT. THE DEVICES WERE REMOVED FROM THE PATIENT AND ALL GUIDE CATHETER PIECES AND STENTS WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH A 7FR X 7CM FLEXIMA BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MARLBOROUGH M00539200 13977672

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention