RX CYTOLOGY BRUSH
Received Mar 12, 2024 · Event occurred Feb 15, 2024
Report 3005099803-2024-00877 · MDR key 18883261
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0032411119
Product problems
- Break
- Adverse Event Without Identified Device or Use Problem
- Break
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF WIRE BREAK. BLOCK H10: INVESTIGATION RESULTS. THE RETURNED RX CYTOLOGY BRUSH WAS ANALYZED, AND IT WAS FOUND THAT THE WIRE WAS DAMAGED (BUCKLED) INSIDE THE INJECTION PORT, AND IT WAS NOT BROKEN. IN ADDITION, THE HANDLE WAS NOT BROKEN. THE REPORTED EVENTS OF HANDLE AND WIRE BREAK WERE NOT CONFIRMED. THE INVESTIGATION FINDING OF WIRE DAMAGED (BUCKLED) COULD HAVE BEEN GENERATED DUE TO EXCESSIVE FORCE APPLIED POSSIBLY CAUSING THE WORKING LENGTH TO KINK WHEN THE BRUSH WAS EXTENDED OR RETRACTED. BASED ON ALL AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT IS NO PROBLEM DETECTED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE IN THE SHEATH WAS DAMAGED/DEFECTIVE. IT WAS ALSO REPORTED THAT THE HANDLE WAS DIFFICULT TO OPERATE, AND AN UNUSUAL NOISE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MALFUNCTION OF THE DEVICE, DESPITE GOOD FAITH EFFORTS.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE IN THE SHEATH WAS DAMAGED/DEFECTIVE. IT WAS ALSO REPORTED THAT THE HANDLE WAS DIFFICULT TO OPERATE, AND AN UNUSUAL NOISE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MALFUNCTION OF THE DEVICE, DESPITE GOOD FAITH EFFORTS.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF WIRE BREAK.