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

Model Number M00545000

Device Problems Break (1069); Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Investigation results: an rx cytology brush was returned for analysis.A visual analysis of the device revealed that the brush was extended when received.The working length (extrusion and pull wire) was kinked/bent near the handle.A functional evaluation was performed and revealed that when the handle was actuated, the brush was unable to retract.The device was disassembled and it was observed that the pull wire was kinked and broken adjacent to the handle cannula joint.No other anomalies were noted.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Likely the failures found (pull wire/catheter kinked/bent, pull wire bent and broken) were caused due to excessive manipulation as the customer brushed back and forth during procedure.Handling and manipulation of the device can lead to kinking of the catheter and pull wire.This condition can cause difficulties to extend/retract the brush, excessive force applied to the handle in order to extend/retract the brush can result in kinking of the pull wire at handle cannula joint.Also continued movements of the handle can result in pull wire breakage.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 bile duct during a cytology procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the brush failed to retract.When the device was visually inspected, the working length was noted to be kinked.The procedure was then completed with another rx cytology brush.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.This event has been deemed an mdr reportable event based on the investigation results which revealed that the pull wire was broken.

• 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: 8573860
• MDR Text Key: 143854214
• Report Number: 3005099803-2019-02330
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0023112331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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