RX CYTOLOGY BRUSH
Received May 28, 2026 · Event occurred Apr 29, 2026
Report 3005099803-2026-02170 · MDR key 25314150
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
M00545000
Lot number
0038364387
Product problems
- Contamination
- Tear, Rip or Hole in Device Packaging
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CYTOLOGY BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION, A LEAK WAS NOTED ON THE TRAY PACKAGING. THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF PACKAGING TEAR, RIP OR HOLE IN DEVICE PACKAGING. IMDRF DEVICE CODE A1801 CAPTURES THE REPORTABLE EVENT OF DEVICE NOT STERILE.