BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 4882446 · Received July 1, 2015

    Report

    Report Number
    3005099803-2015-01781
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    April 21, 2015
    Report Date
    June 8, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FDX
    PMA / PMN Number
    K930348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT OF WIRE BROKE. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE SHOWED THAT THERE WERE MULTIPLE BENDS FOUND IN A SECTION OF THE WORKING LENGTH AND KINKS IN THE PULL WIRE. THE HYPOTUBE HAD BEEN BROKEN AT PROXIMAL END OF HANDLE T-FITTING. THE HYPOTUBE WAS BENT AND EXPOSED. THE BRUSH BRISTLES, WHICH HAS DRIED RED RESIDUE, AND TIP WERE PRESENT, PROPERLY FORMED, AND WITHOUT ISSUE. FUNCTIONAL ANALYSIS SHOWED THAT THERE WAS RESISTANCE WHEN THE BRUSH WAS ATTEMPTED TO EXTEND WITH THE USE OF PLIERS ON THE EXPOSED SECTION OF THE HYPOTUBE. THE EVENT WAS MOST LIKELY CAUSED BY SOME OPERATIONAL OR ANATOMICAL ASPECT OF THE PROCEDURE WHICH RESTRICTED THE PULL WIRE¿S ABILITY TO MOVE FREELY WITHIN THE CATHETER. ATTEMPTS TO EXTEND AND RETRACT THE BRUSH WITH PULL WIRE MOVEMENT RESTRICTED RESULTED IN THE BENT AND BROKEN THUMB RING AND BROKEN PULL WIRE. THEREFORE, THE MOST PROBABLY ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE BILIARY DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BRUSH GOT STUCK IN THE CANNULA AND COULD NO LONGER ADVANCE FURTHER. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: WIRE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425798 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 17641393

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR