BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1052539 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00526
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED, THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE 2008 15-MONTH RAPID EXCHANGE BILIARY STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING A STENT PLACEMENT PROCEDURE ON MALE PATIENT (AGE AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, AFTER STENT DEPLOYMENT, A FLUOROSCOPIC IMAGE REVEALED THAT "THE TIP OF THE GUIDE CATHETER WAS TORN AND [REMAINED] INSIDE THE RELEASED STENT." IN ADDITION, "THE STENT WAS [POSITIONED] IN THE [DUODENUM]." A SECOND BILIARY STENT (OLYMPUS, PIGTAIL) WAS PLACED. THE TIP OF THE CATHETER WAS REMOVED BY FORCEPS FROM THE FIRST STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545580 11299904

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK