RX CYTOLOGY BRUSH
Received May 7, 2026 · Event occurred Apr 1, 2026
Report 3005099803-2026-01672 · MDR key 25116556
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
M00545000
Lot number
0037463317
Product problems
- Detachment of Device or Device Component
Patient
NA · 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 USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON AN UNKNOWN DATE. DURING PREPARATION, WHILE RETRACTING THE BRUSH, THE INTERNAL MECHANISM FAILED, CAUSING THE COMPONENT TO SNAP. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.
Additional Manufacturer Narrative
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: DEVICE CODE A0501 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF BRUSH DETACHMENT OF DEVICE OR DEVICE COMPONENT.