RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

(B)(4). 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.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BRISTLED PORTION OF THE BRUSH WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD ¿NO INJURY¿ AT THE CONCLUSION OF THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

AN RX CYTOLOGY BRUSH WAS RETURNED FOR ANALYSIS. A VISUAL EVALUATION OF THE RETURNED RX CYTOLOGY BRUSH REVEALED THAT THE HANDLE CANNULA WAS BROKEN AT THE PROXIMAL END AND THERE IS EVIDENCE THAT THE HANDLE CANNULA WAS KINKED IN SEVERAL LOCATIONS. NO VISUAL ISSUES WERE IDENTIFIED WITH THE BRISTLED SECTION OF THE DEVICE; IT IS FREE FROM KINKS AND BENDS. THE REPORTED EVENT THAT THE BRUSH SECTION WAS BENT COULD NOT BE CONFIRMED. THE RETURNED DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUES, OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THEREFORE, THE MOST PROBABLE CAUSE FOR THIS COMPLAINT IS NOT CONFIRMED- RETURNED, SINCE THE COMPLAINT INCLUDED A RETURNED DEVICE REVIEW (VISUAL AND PHYSICAL) WHICH SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE FAILURES FOUND (HANDLE CANNULA KINKED AND BROKEN) ARE ISSUES THAT COULD HAVE BEEN GENERATED BY EXCESSIVE MANIPULATION OF THE DEVICE BY THE USER AND/OR EXCESS OF FORCE APPLIED TO THE PRODUCT. THE INVESTIGATION CONCLUDED THAT THE OBSERVED FAILURES ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THESE FINDINGS ARE OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BRISTLED PORTION OF THE BRUSH WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD ¿NO INJURY¿ AT THE CONCLUSION OF THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.