BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1230999 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05549
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    SAME CASE AS MFR REPORT # 3005099803-2008-05550. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, TRACKING DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN AN UNSPECIFIED BILIARY DUCT. THE PHYSICIAN ATTEMPTED TO BACK-LOAD THE RX 7 X 7CM STENT DELIVERY SYSTEM (SDS) OVER AN UNSPECIFIED GUIDE WIRE, HOWEVER, THE GUIDE WIRE "PUSHED THE METAL WIRE THAT CONTROLS THE INTRODUCER OUT THE SIDE PORT". THE PHYSICIAN REMOVED THE DEVICE AND ATTEMPTED TO BACK-LOAD A SECOND OF THE SAME DEVICE, HOWEVER, "A SIMILAR PROBLEM [OCCURRED] AND THE CLEAR INTRODUCER CAME OFF COMPLETELY". THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00545560

    Patients

    Seq Age Sex Outcome Treatment
    1