IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6)2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH WOULD BEND DURING BRUSHING BECAUSE IT WAS NOT RIGID ENOUGH. A SECOND CELEBRITY CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE, SINCE THE USER WAS UNABLE TO EXTEND THE BRUSH BACK OUT OF THE SHEATH. 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.
N
Patient 1
THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. REPORTED EVENT: BRUSH BENT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.
N
Patient 1
VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND DEVICE TO BE RETRACTED AND COVERED WITH RESIDUE. THE CATHETER AND THE DRIVE WIRE WERE BENT IN MULTIPLE PLACES, WHICH PREVENTED THE BRUSH FROM EXTENDING DURING FUNCTIONAL TESTING. HOWEVER, THE BRUSH WAS ABLE TO EXTEND WHEN THE CATHETER WAS HELD TAUT. AT THIS TIME, IT WAS NOTED THAT THE BRUSH WAS NOT BENT. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE BRUSH WAS BENT; HOWEVER, THE COMPLAINT THAT THE BRUSH WAS DIFFICULT TO EXTEND WAS CONFIRMED. TORTUOUS ANATOMY AND OTHER OPERATIONAL FACTORS CAN CAUSE THE WORKING LENGTH TO BEND. ONCE THE WORKING LENGTH IS BENT, IT WOULD BE DIFFICULT TO ACTUATE THE BRUSH. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE IDENTIFIED FAILURES IS OPERATIONAL CONTEXT.
D
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRUSH WOULD BEND DURING BRUSHING BECAUSE IT WAS NOT RIGID ENOUGH. A SECOND CELEBRITY CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE, SINCE THE USER WAS UNABLE TO EXTEND THE BRUSH BACK OUT OF THE SHEATH. 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.