RX CYTOLOGY BRUSH
Received Mar 22, 2024 · Event occurred Feb 27, 2024
Report 3005099803-2024-01079 · MDR key 18957076
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0029249424
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH DETACHMENT.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2024. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE BRISTLES OF THE BRUSH WERE BROKEN/MISSING. THE PROCEDURE WAS COMPLETED USING ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.