BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1911989 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-04963
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED UN-OPENED TRAY REVEALED 2 AREAS WITH FOREIGN MATERIAL ON THE PUSH CATHETER. EXAMINATION OF THE FIRST AREA REVEALED 2 PIECES OF BLACK FIBER WITH THE LONGEST PIECE MEASURING APPROXIMATELY 1.5 MILLIMETERS. EXAMINATION OF THE SECOND AREA REVEALED A CLUMP OF FIBER MEASURING APPROXIMATELY 4 MILLIMETERS IN LENGTH. THE DEVICE WAS RECEIVED WITH A RED MARK WHICH DESIGNATED THE LOCATIONS OF THE FOREIGN MATERIAL. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS SUPPLIER MANUFACTURING. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT. THE DEVICE HAS BEEN RECEIVED; HOWEVER THE EVALUATION HAS NOT YET BEEN COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS RECEIVED FROM A CUSTOMER BY A BOSTON SCIENTIFIC DISTRIBUTION CENTER. DURING INSPECTION OF THE RETURNED FLEXIMA BILIARY STENT SYSTEM, A HAIR/WOOL-LIKE FIBER WAS NOTED IN THE SEALED PACKAGING. THERE NO DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS RECEIVED FROM A CUSTOMER BY A BOSTON SCIENTIFIC DISTRIBUTION CENTER. DURING INSPECTION OF THE RETURNED FLEXIMA BILIARY STENT SYSTEM, A HAIR/WOOL-LIKE FIBER WAS NOTED IN THE SEALED PACKAGING. THERE NO DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

    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 M00539340 13487028

    Patients

    Seq Age Sex Outcome Treatment
    1