inforMED
MalfunctionFDX

RX CYTOLOGY BRUSH

Received Jul 5, 2018

Report 3005099803-2018-02164 · MDR key 7664976

Device

Generic name

Endoscopic Cytology Brush

Model number

M00545000

Catalog number

4500

Lot number

21056238

Product problems

  • Bent
  • Bent

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

DEVICE COMPONENT CODE RELATES TO DEVICE PROBLEM CODE FOR THE REPORTED EVENT OF BRUSH BENT. 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 MDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS OPENED FOR USE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE BRISTLED PORTION OF THE BRUSH WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. 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 FINE.