RX CYTOLOGY BRUSH
Received Mar 8, 2019 · Event occurred Feb 18, 2019
Report 3005099803-2019-01094 · MDR key 8403366
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0022763114
Product problems
- Mechanical Problem
- Material Twisted/Bent
- Mechanical Problem
- 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 USED DURING A SCRAPING CYTOLOGY PROCEDURE PERFORMED IN THE PAPILLA ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THE BRISTLED PORTION OF THE BRUSH WAS BENT. THE DEVICE WAS STILL UTILIZED AND SCRAPING WAS ATTEMPTED BY INSERTING THE DEVICE INTO THE DUODENUM FIBER, HOWEVER, THE BRUSH FAILED TO EXTEND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE HEALTH CARE FACILITY ADDRESS IS (B)(4). DEVICE PROBLEM CODE 2981 CAPTURES THE REPORTABLE EVENT OF BRUSH BENT. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DEVICE WAS IN GOOD CONDITION WITHOUT EVIDENCE OF DAMAGES. NO BENT, KINKED OR DEFORMED SECTIONS WERE NOTED AND THE DISTAL END (BRUSH) HAD NO ISSUES. FUNCTIONAL INSPECTION WAS PERFORMED AND THE BRUSH WAS ABLE TO EXTEND AND RETRACT. DIMENSIONAL INSPECTION WAS ALSO PERFORMED AND THE RESULTS FOUND WERE WITHIN MANUFACTURING SPECIFICATION. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE IS "NO PROBLEM DETECTED." 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). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER 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 MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS USED DURING A SCRAPING CYTOLOGY PROCEDURE PERFORMED IN THE PAPILLA ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THE BRISTLED PORTION OF THE BRUSH WAS BENT. THE DEVICE WAS STILL UTILIZED AND SCRAPING WAS ATTEMPTED BY INSERTING THE DEVICE INTO THE DUODENUM FIBER, HOWEVER, THE BRUSH FAILED TO EXTEND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.