NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2012-02329 AND 3005099803-2012-02429 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CELLEBRITY CYTOLOGY BRUSHES WERE USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PULL WIRES OF ALL THREE DEVICES BROKE NEAR THEIR RESPECTIVE HANDLES, AND THE WIRES WERE PROTRUDING THROUGH THE SHEATHS. IT WAS ALSO REPORTED THAT THE WORKING LENGTHS OF ALL THREE DEVICES WERE KINKED. AS NONE OF THE BRUSHES COULD BE EXTENDED INTO THE PATIENT'S BRONCHUS, THE PROCEDURE WAS COMPLETED WITH ANOTHER CELLEBRITY CYTOLOGY BRUSH. IT WAS CONFIRMED THAT THE USER REMOVED ALL THREE BRISTLE BRUSHES PRIOR TO RETURNING THE PRODUCTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE.
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Patient 1
THE INVESTIGATION FINDINGS: DIFFICULTY RETRACTING BRUSH. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE WORKING LENGTH TO BE KINKED AND BUCKLED IN SEVERAL LOCATIONS, CAUSING THE WORKING LENGTH TO BUNCH WHEN THE HANDLE WAS ACTUATED. RESISTANCE WAS ENCOUNTERED DURING RETRACTION OF THE DEVICE WITH THE SHEATH HELD STRAIGHT, BUT THE DEVICE WOULD NOT EXTEND. THE BRISTLE BRUSH WAS NOT PRESENT. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE PULL WIRE BROKE AND THE WIRE WAS PROTRUDING THROUGH THE SHEATH; THE COMPLAINT WAS NOT CONFIRMED. HOWEVER, AS DIFFICULTY RETRACTING THE DEVICE WAS ENCOUNTERED, THE EVENT REMAINS MDR-REPORTABLE. THE MOST PROBABLE ROOT CAUSE OF THE DEFECTS IDENTIFIED IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.