RX CYTOLOGY BRUSH
Received Mar 7, 2019 · Event occurred Feb 12, 2019
Report 3005099803-2019-01025 · MDR key 8399009
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
22642400
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS OPENED FOR USE DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, WHEN THE DEVICE WAS UNPACKED, THE DEVICE WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE INITIAL REPORTER'S CITY IS (B)(6). PROBLEM CODE 2981 CAPTURES THE REPORTABLE EVENT OF BRUSH BENT. INVESTIGATION RESULTS: AN RX CYTOLOGY BRUSH WAS RECEIVED FOR ANALYSIS. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BRUSH WAS EXTENDED WHEN RECEIVED AND THE BRUSH SECTION HAD RESIDUES INDICATING USE AND HANDLING. THE DISTAL SECTION OF THE DEVICE (BRUSH SECTION) WAS KINKED. NO OTHER ANOMALIES WERE NOTED. IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE USE OF THE DEVICE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. HANDLING AND MANIPULATION OF THE DEVICE DURING ITS USE CAN LEAD TO KINKING OF THE DISTAL SECTION. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE IS "ADVERSE EVENT RELATED TO PROCEDURE" SINCE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT. 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.
Additional Manufacturer Narrative
(B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS OPENED FOR USE DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, WHEN THE DEVICE WAS UNPACKED, THE DEVICE WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.