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

Model Number M00545000

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: the returned rx cytology brush was analyzed, and a visual evaluation noted that the device returned without the brush.The pull wire was kinked, the working length showed remnants of use, and the internal pull wire was returned outside of the working length.In addition, the handle was bent.The handle was disassembled and the pull wire was detached from the handle.No other problems were noted.The reported complaint of brush bent cannot be confirmed since the brush was not returned.It was not possible to carry out a more thorough investigation to determine the influence of this part in the event.Therefore, the most probable root cause for the problem reported is "no problem detected".The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.It was possible that due to the manipulation or the technique used at the time to interact with the device, in conjunction with the patient's tortuosity or anatomical conditions could have affected the functionality of the device, (it was reported that the device was used in a tortuous position); then, an excess force could have been applied, bending the handle and the internal pull wire, and causing the detachment.Based on the information available and the returned device analysis, the most probable root cause for the problems found during analysis is adverse event related to procedure.This is defined as 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.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the biliary during a biliary tissue sampling procedure performed on (b)(6) 2022.During the procedure and inside the patient, the bristled portion of the brush was bent.The device was in a tortuous position when the problem occurred.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of brush detachment.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: 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; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14807125
• MDR Text Key: 296183241
• Report Number: 3005099803-2022-03416
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0028713488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female