IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED DURING A PULMONARY BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE USER ATTEMPTED TO RETRACT THE DEVICE AFTER BRUSHING THE BRONCHI, THE PULL WIRE TORE NEAR THE HANDLE INSIDE THE SCOPE. NO PIECES DETACHED INSIDE THE PATIENT. SINCE THE HANDLE AND PULL WIRE WERE SEPARATED, IT WAS REPORTED THAT THE PULL WIRE PROBABLY REMAINED INSIDE THE SCOPE AFTER BEING TORN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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.
N
Patient 1
VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PULL WIRE HAD SEPARATED FROM THE HANDLE CANNULA; THE PULL WIRE HAD BEEN COMPLETELY REMOVED FROM THE SHEATH. THE PULL WIRE WAS BENT NEAR THE DISTAL TIP, AND THE OUTER SHEATH WAS KINKED IN SEVERAL LOCATIONS. THE HANDLE CANNULA FUNCTIONED SMOOTHLY. THE HANDLE WAS THEN DISASSEMBLED AND IT WAS NOTED THAT THERE WERE CRIMP MARKS PRESENT ON ALL FOUR SIDES OF THE HANDLE CANNULA AND SCRATCHES ON THE PROXIMAL END OF THE PULL WIRE, INDICATING PROPER CRIMPING DURING MANUFACTURING. ADDITIONALLY, THE PROXIMAL END OF THE PULL WIRE WAS FED BACK INTO THE HANDLE CANNULA, BUT IT WOULD NOT PASS THROUGH THE CRIMPED AREA. THE COMPLAINT WAS CONFIRMED; THE PULL WIRE HAD SEPARATED FROM THE HANDLE CANNULA, RESULTING IN A "TORN" APPEARANCE. AS EVIDENCE WAS FOUND THAT THE DEVICE WAS ASSEMBLED PROPERLY DURING MANUFACTURING, IT IS MORE LIKELY THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE, SUBSEQUENTLY CAUSING THE SEPARATION. THEREFORE, 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. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.
N
Patient 1
EVENT DATE IS UNKNOWN. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
D
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CELEBRITY CYTOLOGY BRUSH WAS USED DURING A PULMONARY BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE USER ATTEMPTED TO RETRACT THE DEVICE AFTER BRUSHING THE BRONCHI, THE PULL WIRE TORE NEAR THE HANDLE INSIDE THE SCOPE. NO PIECES DETACHED INSIDE THE PATIENT. SINCE THE HANDLE AND PULL WIRE WERE SEPARATED, IT WAS REPORTED THAT THE PULL WIRE PROBABLY REMAINED INSIDE THE SCOPE AFTER BEING TORN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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.