BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1628718 · Received March 11, 2010

    Report

    Report Number
    3005099803-2010-01205
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) THERAPY/NON-SURGICAL TREATMENT, ADDITIONAL. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT OF A (B) (6) FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE DEPLOYMENT OF THE STENT, THE INTRODUCER/GUIDE CATHETER BECAME SEPARATED AND REMAINED INSIDE THE DEPLOYED STENT. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP PROCEDURE, THE FOLLOWING WEEK, WHERE THE INTRODUCER/CATHETER AND STENT, INSIDE THE PATIENT, WERE REMOVED AND ANOTHER RAPID EXCHANGE PLASTIC BILIARY STENT WAS DEPLOYED WITH NO 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 - SPENCER M00545560 12779162

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR