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

Model Number M00545000

Device Problem Break (1069)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Investigation results a visual evaluation of the returned rx cytology brush revealed that the pull wire was broken at the distal end of handle cannula, and it was also noticed that a kink was found in the same location.The extrusion is free from obvious kinks and bends.Further evaluation noted that the bristled portion of the brush was cut by the customer with a sharp tool.A functional analysis was not performed due to the condition of the returned device.It is most likely that the pull wire being kinked at the distal end of the handle cannula could have caused difficulty to extend/ retract the brush.Due to excessive manipulation of the device, it would cause the pull wire to break.Based on all gathered information, the most probable cause of this complaint is ¿manufacturing process design¿, since it is most likely that design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and no deviations were found.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the brush was difficult to extend and retract.The procedure was completed with this device.There was ¿no serious injury¿ reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.This event has been deemed a mdr reportable event based on the investigation results; wire broke.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7342066
• MDR Text Key: 102592816
• Report Number: 3005099803-2018-00795
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 03/08/2018

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: 12/07/2019
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 21482135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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
• Patient Age: 35 YR