inforMED
MalfunctionFDX

RX CYTOLOGY BRUSH

Received Oct 11, 2018 · Event occurred Sep 17, 2018

Report 3005099803-2018-60798 · MDR key 7957747

Device

Generic name

Endoscopic Cytology Brush

Model number

M00545000

Catalog number

49275

Lot number

0022144404

Product problems

  • Material Twisted/Bent
  • Material Twisted/Bent

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. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY WIREGUIDED BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH WAS NOTICED TO BE KINKED. 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 OKAY.

Additional Manufacturer Narrative

(B)(4). ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DISTAL END (BRUSH SECTION) WAS BENT. DURING FUNCTIONAL INSPECTION, THE HANDLE WAS ACTUATED AND THE BRUSH WAS ABLE TO BE EXTENDED AND RETRACTED WITHOUT ANY ISSUES. AS PER COMPLAINT INFORMATION, THE ISSUE OCCURRED DURING THE PROCEDURE. IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING PROCEDURE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. HANDLING AND MANIPULATION OF THE DEVICE DURING PREPARATION/PROCEDURE COULD HAVE CONTRIBUTED WITH THE REPORTED ISSUE. THE FAILURE FOUND (BRUSH BENT) IS AN ISSUE THAT COULD HAVE BEEN GENERATED BY EXCESSIVE MANIPULATION OF THE DEVICE BY THE USER AND/OR EXCESS OF FORCE APPLIED TO THE PRODUCT; ALSO INTERACTION WITH OTHER INSTRUMENT/TOOL SUCH AS THE SCOPE COULD HAVE CAUSED THE DAMAGE FOUND. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CAUSE TRACED TO COMPONENT FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASED FOR DISTRIBUTION.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY WIREGUIDED BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BRISTLED PORTION OF THE BRUSH WAS NOTICED TO BE KINKED. 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 OKAY.