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

Model Number M00545000

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation results: an rx cytology brush was returned for analysis.A visual analysis of the returned device revealed that the brush was partially retracted when received.The working length (pull wire and extrusion) was kinked in several locations and the distal end of the pull wire (tip of the brush) was also bent.A functional inspection revealed that the device was unable to extend and retract when the handle was actuated.A dimensional inspection was also performed and the device was measured and found to be within manufacturing specifications.No other issue was noted.The failures found (working length and brush tip kinked) are issues that could have been generated during the manipulation of the device by the user; once this section of the unit has been damaged it can affect its functionality since these types of defects do not allow the product to perform its function to move backward / forward; hence, the brush section would not extend or retract properly.The kinked condition of the device also could have been the cause of the issues to advance the device.Based on the information available and the analysis performed, the most probable root cause 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 at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that an rx cytology brush wireguided was used in the common bile duct during a cytology procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when retracting the brush into the catheter prior to being inserted into the endoscope, it was noted that the tip was unable to completely retract even when the handle was pulled to the end.When it was inserted into the endoscope along with the guidewire, the brush was unable to advance inside the bile duct and the brush could not be manipulated.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the bristled portion of the brush was bent/kinked.

• 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: 8479896
• MDR Text Key: 140880036
• Report Number: 3005099803-2019-01587
• 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: Physician
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 22775188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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