RX CYTOLOGY BRUSH
Received Nov 18, 2019 · Event occurred Oct 30, 2019
Report 3005099803-2019-05640 · MDR key 9336752
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0024256994
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence 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 WAS PREPARED FOR USE DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE BRUSH WAS BROKEN WHEN IT WAS TESTED PRIOR TO OPERATION. REPORTEDLY, THE DEVICE WAS NEVER USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.