BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 3092027 · Received May 3, 2013

    Report

    Report Number
    3005099803-2013-02911
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED TO BE OVER 65 YEARS OF AGE. (B)(4). VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BRUSH WAS BENT. THE HANDLE CANNULA WAS BENT IN SEVERAL LOCATIONS AND BROKEN/DETACHED APPROXIMATELY 3 CM FROM THE DISTAL END OF THE ORANGE THUMB RING. THE WORKING LENGTH OF THE DEVICE WAS ALSO KINKED IN SEVERAL LOCATIONS AND WAS BENT APPROXIMATELY 5 CM FROM THE DISTAL END. A FUNCTIONAL EVALUATION WAS NOT ABLE TO BE PERFORMED DUE TO THE KINKS. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    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 EXTENDING AND RETRACTING THE BRUSH, THE ORANGE O-RING ON THE HANDLE BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. 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 FINE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING: BRUSH BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194027 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 0015569965

    Patients

    Seq Age Sex Outcome Treatment
    1