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

Model Number M00545000

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The reported healthcare facility and physician information are: dr.(b)(6).(b)(6) hospital (b)(6).Phone number: (b)(6).Fax number: (b)(6).(b)(4).Investigation results: an rx cytology brush was received for analysis.Visual inspection of the returned device revealed that the brush was returned extended and the working length was kinked approximately at 110 cm from the black heat shrink.Also, the handle cap was unscrewed.The device was disassembled, it was observed that the pull wire was broken adjacent to the handle cannula joint.However, due to the condition the functional test could not be performed.No other problems were noted.The reported complaints of wire break and working length detachment of device or device component were confirmed since the analysis of the device found that the pull wire was broken adjacent to the handle cannula joint.Also, the working length was found kinked/bent and this could be due to the amount of force applied and manipulation during the procedure.It is possible that the way in which the device was handled and manipulated may have contributed to the encountered problem (pull wire broken.It is most likely that procedural factors, such as user technique/handling or force excess applied during it use, could have caused the pull wire break and consequently affected the device performance and its integrity.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.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 to diagnose a suspected bile duct cancer in the common bile duct during a specimen collection procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the sheath and wire in the area near the handle was separated and they were unable to use the device.The device was not in a tortuous position when the problem occurred.The procedure was completed with a different brush.There were no patient complications reported as a result of this event.

• 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: 12751944
• MDR Text Key: 280141258
• Report Number: 3005099803-2021-05637
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0027802373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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