MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was prepared for use during a procedure performed on (b)(6) 2019.According to the complainant, during preparation, it was noticed that the brush was broken when it was tested prior to operation.Reportedly, the device was never used inside the patient.The procedure was completed with another rx cytology brush.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was prepared for use during a procedure performed on(b)(6), 2019.According to the complainant, during preparation, it was noticed that the brush was broken when it was tested prior to operation.Reportedly, the device was never used inside the patient.The procedure was completed with another rx cytology brush.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

Block h6: problem code 1069 captures the reportable event of brush wire broken.Block h10: investigation results an rx cytology brush was received for analysis.The device did not have any broken section, the brush was retracted when received; consequently, not confirming the reported issue of "wire break", therefore the investigation conclusion code for the reported issue of "wire break" will be documented as "no problem detected" since the device complaint or problem cannot be confirmed.Visual evaluation of the returned device revealed that the working length (extrusion and pull wire) was bent in several locations and during functional inspection the handle was actuated, however the brush was unable to extend.The device was disassembled and it was observed that the pull wire was kinked adjacent to the handle cannula joint.As per complaint information the issue occurred prior procedure.Handling/manipulation of the device during unpacking/prepping/testing could have contributed with the working length bent and this condition can cause issues to extend the brush due to friction between the components (extrusion/pull wire) at bent areas.Continued attempts to extend the brush or force applied to the handle in order to extend the brush can result in kinking the pull wire at handle cannula joint and as a result the device become unable to extend the brush.Additionally, boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.According to procedure 90271775 ver.An (inspect rx cytology) during manufacturing it is confirmed that the brush extends and retract properly, it the unit does not extend/retract, it is scrapped.This step of the process would have detected the encountered issue.Based on the information available and the analysis performed, the most probable root cause for this problem is adverse event related to procedure.A risk review of the rx cytology brush wireguided 8f 2.1mm was completed using 90388865, risk analysis workbook- biopsy brushes, bsc, av and confirmed that the event of "wire break" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9336804
• MDR Text Key: 189712715
• Report Number: 3005099803-2019-05639
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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: 08/12/2021
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0024256994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/04/2020
• Patient Sequence Number: 1