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

Model Number M00545000

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: an rx cytology brush was returned for analysis.A visual analysis revealed that the working length (extrusion and pull wire) was kinked in several locations.The handle was actuated and the brush was unable to extend.The device was disassembled and it was observed that the pull wire was broken and kinked adjacent to the handle cannula joint.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, pull wire broken) were caused due to manipulation as the customer brushed back and forth during the testing/use of the device.Handling and manipulation of the device can lead to kinking of the catheter and pull wire.This condition can cause difficulties to extend the brush.Force applied to the handle in order to extend the brush can result in kinking 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 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the brush was unable to extend out of the catheter.A second brush was used, however the same issue occured.The procedure was then completed with a third rx cytology brush.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: 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: 8573628
• MDR Text Key: 143943881
• Report Number: 3005099803-2019-02306
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0023268676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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