BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 4152994 · Received October 8, 2014

    Report

    Report Number
    3005099803-2014-03267
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT OF WIRE BROKEN. ANALYSIS OF THE RETURNED RX CYTOLOGY BRUSH DID NOT CONFIRM THE REPORTED COMPLAINT. THE DISTAL PART OF THE CATHETER AND THE BRUSH WERE CUT OFF AND NOT RETURNED, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF THE WORKING LENGTH WAS TOO LONG AND IF THE BRUSH WAS DIFFICULT TO EXTEND. ADDITIONALLY, THE DRIVE WIRE WAS FOUND TO BE BENT AND BROKEN. THEREFORE THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT SINCE RESIDUE WAS FOUND ON THE ENTIRE DEVICE INDICATING THAT IT WAS USED DURING A PROCEDURE. 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. THE COMPLAINT WAS NOT CONFIRMED. THE DEVICE DID NOT SHOW ANY EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    NOTE: THIS EVENT, AS REPORTED, DID NOT REFLECT AN MDR REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE REVEALED AN MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS BEING SUBMITTED BASED ON THE EVALUATION RESULTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN A BRUSH CYTOLOGY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BRUSH FAILED TO EXTEND. IT WAS SUSPECTED THAT THE SHEATH WAS LONGER THAN USUAL. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631985 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000

    Patients

    Seq Age Sex Outcome Treatment
    1