MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number	M00545000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a rx cytology brush was used for cholangiocarcinoma in the common bile duct during a endoscopic pancreato-cholangiography procedure performed on (b)(6) 2022.During the procedure, the wire of the brush was found to be separated before usage so it was unable to use.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code a0401 captures the reportable event of brush wire break.Block h10: investigation results an rx cytology brush was received for analysis.Visual inspection of the returned device revealed that the brush was came back extended.The working length was kinked and there were remnants of use.In addition, the blue knob was unscrewed to inspect the internal condition of the wire and it was noted that the pull wire was broken.No other device problems were noted.The reported complaint of wire break was confirmed since the results of the analysis performed on the returned product showed that the internal pull wire was broken at the junction to the handle.In addition, the working length was kinked.This suggests that the manipulation, the technique used, or the anatomical conditions of the patient may have kinked the working length, so it may have been necessary to apply a greater force which led to the rupture of the internal pull wire.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related.This is defined as the adverse event occurred during the procedure and the device had no influence on event.Block h11: block d4 (lot number) has been updated based on additional information received on september 28, 2022.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used for cholangiocarcinoma in the common bile duct during a endoscopic pancreato-cholangiography procedure performed on (b)(6) 2022.During the procedure, the wire of the brush was found to be separated before usage so it was unable to use.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.

• Brand Name: RX CYTOLOGY BRUSH
• Common Device Name: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; propark, coyol; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15435119
• Report Number: 3005099803-2022-05222
• Device Sequence Number: 5570017
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K930348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2024
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0029566405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown