BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 3944765 · Received July 18, 2014

    Report

    Report Number
    3005099803-2014-02519
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: BRUSH BENT. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION FOUND THAT THE HANDLE CANNULA WAS BENT AND THE WORKING LENGTH WAS TWISTED. FUNCTIONAL TEST WAS PERFORMED, AND RESISTANCE FELT WHEN BRUSH WAS ACTUATED. THE COMPLAINT THAT THE BRUSH BENT WAS NOT CONFIRMED. BRUSH WAS DIFFICULT TO ACTUATE DUE TO THE BENT HANDLE CANNULA. HOWEVER, THE COMPLAINT THAT THE WORKING LENGTH BENT WAS CONFIRMED. THE BRUSH AND THE DRIVE WIRE AT THE DISTAL PART DID NOT HAVE ANY ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS OPENED FOR USE IN THE COMMON BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BRUSH AND THE WORKING LENGTH OF THE DEVICE WERE FOUND TO BE BENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS OPENED FOR USE IN THE COMMON BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BRUSH AND THE WORKING LENGTH OF THE DEVICE WERE FOUND TO BE BENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422747 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 16280733

    Patients

    Seq Age Sex Outcome Treatment
    1