RX CYTOLOGY BRUSH
Received Dec 5, 2018 · Event occurred Nov 16, 2018
Report 3005099803-2018-61743 · MDR key 8132875
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0022536709
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BILIARY RX CYTOLOGY BRUSH WIREGUIDED WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH TIP WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BILIARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BILIARY RX CYTOLOGY BRUSH WIREGUIDED WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH TIP WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BILIARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Additional Manufacturer Narrative
PROBLEM CODE 2981 CAPTURES THE REPORTABLE EVENT OF BRUSH BENT. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT NO VISUAL DEFECTS WERE NOTED, THE RETURNED DEVICE LOOKED UNDER GOOD CONDITIONS WITHOUT EVIDENCE OF DAMAGES. THE BRUSH (BRISTLED PORTION) WAS NOT KINKED/BENT. FUNCTIONAL EVALUATION WAS PERFORMED AND REVEALED THAT WHEN THE HANDLE WAS ACTUATED, THE BRUSH WAS ABLE TO EXTEND AND RETRACT WITHOUT ANY ISSUES. 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.