RX CYTOLOGY BRUSH

Additional Manufacturer Narrative

(B)(4). INVESTIGATION RESULTS: ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BRUSH WAS PARTIALLY EXTENDED WHEN RECEIVED. THE EXTRUSION WAS FREE OF OBVIOUS KINKS AND BENDS. THE DISTAL END OF THE BRUSH WAS KINKED AND DUE TO THIS CONDITION, IT WAS UNABLE TO BE RETRACTED. AS PER COMPLAINT INFORMATION THE ISSUE OCCURRED DURING PREPARATION, HANDLING AND MANIPULATION OF THE DEVICE DURING PREPARATION/UNPACKING CAN LEAD TO KINK THE BRUSH AT DISTAL END, ONCE THE DISTAL END OF THE BRUSH IS KINKED, IT WOULD NOT BE ABLE TO BE RETRACTED SINCE THE KINKED SECTION WOULD IMPEDE THE CORRECT THE RETRACTION OF THE BRUSH. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS TO BE USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, WHEN THE PACKAGE WAS OPENED THE PRODUCT WAS NOTED TO BE DEFECTIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE DISTAL SECTION OF THE BRUSH WAS KINKED.