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

Model Number M00545000

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation results: an rx cytology brush was returned for analysis.A visual evaluation of the returned device revealed that the brush was extended when received.The working length (extrusion and pull wire) was kinked in several locations.Additionally, the distal section of the device (brush section) was kinked.No other anomalies were noted.Handling and manipulation of the device during its use can lead to kinking/bending of the device in several locations, including the distal section.Also interaction with the scope could have contributed with the reported event, since the device could have been hit against the scope while it was being introduced.This could have kinked/bent the device.Based on the information available and the analysis performed, the most probable root cause classification for this event 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 opened for use in the bile duct during a diagnostic procedure performed on (b)(6) 2019.According to the complainant, prior to the procedure, when the device was introduced into the working channel, it was noted that the catheter was bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.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.

• 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: 8500996
• MDR Text Key: 141575146
• Report Number: 3005099803-2019-01836
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/10/2019

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: 11/19/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 22967996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• 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