BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2063298 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01440
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE ISSUE OF GUIDE CATHETER BROKEN. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE OF A (B)(6) MALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER BROKE, HOWEVER THE STENT WAS ABLE TO BE DEPLOYED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE SCOPE'S REACH ALLOWING THE DEVICE TO BE REMOVED AS THE SCOPE WAS WITHDRAWN FROM THE PATIENT. THERE WERE NO DEVICE FRAGMENTS LEFT IN THE PATIENT OR REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION 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 M00545630 13841410

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR