RX CYTOLOGY BRUSH
Received Nov 14, 2019 · Event occurred Oct 28, 2019
Report 3005099803-2019-05520 · MDR key 9320950
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0024051873
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE BRUSHING THE BILE DUCT, BRISTLES OF THE BRUSH DETACHED AND FELL INSIDE THE PATIENT. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUROUS AND THE SCOPE NOT PLACED IN A TORTUROUS PATH. THE DOCTOR ATTEMPTED TO REMOVE THE DETACHED BRISTLES FROM INSIDE THE PATIENT USING ASPIRATION AND SNARING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.