RX CYTOLOGY BRUSH
Received Jun 8, 2021 · Event occurred May 10, 2021
Report 3005099803-2021-02491 · MDR key 11956453
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Boston Scientific CorporationModel number
M00545000Catalog number
4500
Lot number
0026743178
Product problems
- Mechanical Problem
- Material Deformation
- Appropriate Device Problem Term/Code Not Available
- Mechanical Problem
- Material Deformation
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4). THE SUSPECT DEVICE WAS CONTAMINATED 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 COMMON BILE DUCT AREA TO DIAGNOSE A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT EXTEND THE BRUSH OUTSIDE OF THE CATHETER. AFTER THREE ATTEMPTS, THE DEVICE WAS INSPECTED AND IT WAS NOTED THAT THE WIRE WAS KINKED INSIDE THE CATHETER. THEY TRIED TO PUSH THE BRUSH OUT OF THE CATHETER WHEN IT WAS OUTSIDE OF THE PATIENT, BUT IT DID NOT COME OUT. THE DEVICE WAS NOT MANIPULATED IN ANY WAY BEFORE THE PROCEDURE AND IT WAS NOT IN A TORTUOUS POSITION WHEN THE PROBLEM OCCURRED. THERE WERE NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS ABORTED AND WAS NOT COMPLETED DUE TO THIS EVENT. THERE ARE NO KNOWN PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.