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 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2019 as no event date was reported.(b)(4).An rx cytology brush wireguided was returned for evaluation.Analysis of the returned device revealed that the brush was extended when received.The distal section of the device (brush section) was kinked and the working length (extrusion and pull wire) was also kinked in several locations.No other anomalies were noted.As per gathered information the issue occurred during preparation.It is most likely that handling and manipulation of the device during unpacking/prepping could have affected the device performance and its integrity.It is possible that the way in which the device was manipulated could have contributed with the kinks that were found in the working length and brush section.Based on the information available and the analysis performed, the most probable root cause classification is "adverse event related to procedure." a review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that an rx cytology brush wireguided was to be used during a brush cytology procedure preformed on an unknown date.According to the complainant, during preparation and outside the patient, when the device was unpacked and checked, the tip part of the wire inside the catheter was noted to be deformed.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 distal section of the device (brush section) was 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: 8360356
• MDR Text Key: 136857078
• Report Number: 3005099803-2019-00886
• 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: 02/21/2019

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: 10/21/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0022828408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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