RX CYTOLOGY BRUSH
Received Jan 16, 2019 · Event occurred Dec 19, 2018
Report 3005099803-2019-00110 · MDR key 8255077
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0022828408
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WIREGUIDED WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WIRE NEXT TO THE HANDLE WAS BROKEN. IN ADDITION, THE ORANGE THUMB RING AND THE METAL PART WAS ALSO NOTED TO BE BROKEN. REPORTEDLY, THE CYTOLOGY BRUSH WAS IN PATIENT'S BILE DUCT WHEN THE DEVICE BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.