BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

    MDR report key: 1842768 · Received September 23, 2010

    Report

    Report Number
    3005099803-2010-04102
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT PROVIDED TWO POSSIBLE LOT NUMBERS FOR THE COMPLAINT DEVICE.THE 13400973 WITH A LOT EXPIRATION DATE OF 4/18/2012 AND A DEVICE MANUFACTURE DATE OF 4/21/2010.THE 13285956; WITH A LOT EXPIRATION DATE OF 2/24/2012 AND A DEVICE MANUFACTURE DATE OF 2/27/2010.THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SURGEON DECIDED TO DO A CYTOLOGY BRUSHING OF THE STRICTURE AFTER CANNULATING THE BILE DUCT. THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE RX CYTOLOGY BRUSH OVER THE WIRE AND DOWN THE SCOPE. THE RX CYTOLOGY BRUSH WAS REMOVED AND IT WAS NOTED THAT PLASTIC OF THE GUIDEWIRE PORT HAD SPLIT. IT WAS NOT NOTICED AT THIS TIME THAT THE RADIOPAQUE MARKER OF THE DEVICE HAD DETACHED INSIDE THE SCOPE. ANOTHER RX CYTOLOGY BRUSH WAS ADVANCED DOWN THE SCOPE. THE RADIOPAQUE MARKER OF THE FIRST BRUSH WAS PUSHED INTO THE PATIENT'S BILE DUCT WHEN THE SECOND DEVICE WAS ADVANCED. THE RADIOPAQUE MARKER WAS NOT RETRIEVED. A SECOND PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH THE SECOND RX CYTOLOGY BRUSH. THE PATIENT'S CONDITION WAS REPORTED AS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000

    Patients

    Seq Age Sex Outcome Treatment
    1