BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 3092617 · Received May 3, 2013

    Report

    Report Number
    3005099803-2013-03293
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: BRUSH BENT. (B)(4) FOR THE REPORTED EVENT: TIP OF BRUSH DETACHED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE WAS ADVANCED THROUGH THE SCOPE, THE BRUSH BENT IN THE SCOPE. WHEN THE DEVICE WAS ADVANCED INTO THE COMMON BILE DUCT, THE TIP OF THE BRUSH BROKE OFF. AN ATTEMPT WAS MADE TO RETRIEVE THE BRUSH FRAGMENT, BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN IS NOT CONCERNED ABOUT THE UNRETRIEVED FRAGMENT, AS IT IS EXPECTED TO PASS NATURALLY. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193943 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 15330002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR