BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX CYTOLOGY BRUSH

    MDR report key: 2990127 · Received March 5, 2013

    Report

    Report Number
    3005099803-2013-01452
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BRUSH WAS NOT FULLY RETRACTED UPON RECEIPT. FUNCTIONAL EVALUATION FOUND THAT THE BRUSH WOULD EXTEND AND RETRACT; HOWEVER, THE BRUSH WOULD NOT RETRACT FULLY INTO THE CATHETER. WHEN THE BRUSH WAS RETRACTED, THE DISTANCE BETWEEN THE PROXIMAL END OF THE GROOVE AT THE DISTAL END OF THE EXTRUSION AND THE TIP OF THE BRUSH WAS MEASURED AND FOUND TO BE SHORTER THAN SPECIFICATION. THE WORKING LENGTH AND BRUSH EXTENSION LENGTH WERE MEASURED AND FOUND TO MEET SPECIFICATIONS. THE BRUSH WIRE ASSEMBLY WAS FOUND TO BE BENT/KINKED IN SEVERAL LOCATIONS ALONG THE WORKING LENGTH. THE BRUSH WAS NOT BENT. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS HANDLING DAMAGE. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: BRUSH WOULD NOT RETRACT COMPLETELY. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN RX CYTOLOGY BRUSH DEVICES USED DURING THE SAME PROCEDURE (MANUFACTURER REPORTS # 3005099803-2013-01451, 3005099803-2013-01452, 3005099803-2013-01453, 3005099803-2013-01454, 3005099803-2013-01455, 3005099803-2013-01456, AND 3005099803-2013-01457). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SEVEN RX CYTOLOGY BRUSHES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OF EACH DEVICE, WHEN THE DEVICE WAS TESTED, THE BRUSH WOULD NOT FULLY RETRACT BACK INTO THE SHEATH. THIS EVENT TOOK PLACE OUTSIDE THE PATIENT. THE SAME EVENT TOOK PLACE FOR EACH OF THESE SEVEN RX CYTOLOGY BRUSHES USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN EIGHTH 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

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN RX CYTOLOGY BRUSH DEVICES USED DURING THE SAME PROCEDURE. (MANUFACTURER REPORTS # 3005099803-2013-01451, 3005099803-2013-01452, 3005099803-2013-01453, 3005099803-2013-01454, 3005099803-2013-01455, 3005099803-2013-01456, AND 3005099803-2013-01457.) IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SEVEN RX CYTOLOGY BRUSHES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OF EACH DEVICE, WHEN THE DEVICE WAS TESTED, THE BRUSH WOULD NOT FULLY RETRACT BACK INTO THE SHEATH. THIS EVENT TOOK PLACE OUTSIDE THE PATIENT. THE SAME EVENT TOOK PLACE FOR EACH OF THESE SEVEN RX CYTOLOGY BRUSHES USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN EIGHTH 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
    93343 RX CYTOLOGY BRUSH ENDOSCOPIC CYTOLOGY BRUSH FDX BOSTON SCIENTIFIC - SPENCER M00545000 0015726744

    Patients

    Seq Age Sex Outcome Treatment
    1