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

Model Number M00545000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

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.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the common bile duct of a patient with fever and high bilirubin during a procedure performed on (b)(6) 2021.It was reported that during preparation and outside the patient, while unpacking the device the physician found that there was no brush on the front end of the cytology brush and only the bristled parts of the brush were missing.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 following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a0501 captures the reportable event of brush detached.Block h10: investigation results: an rx cytology brush was received for analysis.Visual inspection of the returned device revealed that the working length (extrusion and pull wire) was kinked in several locations, approximately at 70cm, 23cm, 110cm and 17cm from the black heat shrink.Additionally, device was disassembled and it was observed that the pull wire was broken adjacent to the handle cannula joint.Due to the device condition the functional assessment could not be performed.Through the microscope, it was observed that the brush was broken and was not returned.No other issues were noted.Therefore, the reported event of brush detached was confirmed.In summary, based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process; during the product analysis the working length was found kinked/bent and the brush was broken.It is possible that the way in which the device was handled and manipulated, it may have contributed to the encountered failure (brush detachment of device or device component and handle detachment/separate), as per complaint information the issue occurred during the preparation, it is most likely that handling and manipulation of the device during its use could have contributed to the encountered issues.An excessive force applied to the device when they tried to the actuate can lead to the brush was broken.In addition the handle cannula was found kinked/bent, this could be due to the amount of force applied and manipulation during the procedure, this condition could result in the pull wire being broken from the handle cannula.Based on the information available and the analysis performed, the investigation conclusion code for the complaint event will be documented as "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.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 release for distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was prepared for use in the common bile duct of a patient with fever and high bilirubin during a procedure performed on (b)(6) 2021.It was reported that during preparation and outside the patient, while unpacking the device the physician found that there was no brush on the front end of the cytology brush and only the bristled parts of the brush were missing.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 following the procedure was reported to be stable.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11718407
• MDR Text Key: 247251480
• Report Number: 3005099803-2021-01829
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0023819453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 53