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

Model Number M00545000

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the inner catheter, at the base of the handle of the brush, broke when using the cytology brush.In addition, it was also reported that the brush seemed hard to extend/retract from the beginning of usage.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: problem code 2907 captures the reportable event of working length detached/separated.Block h10: an rx cytology brush was received for analysis.Visual evaluation of the returned device revealed that the working length (extrusion and pull wire) was kinked in several locations.The pull wire was kinked and broken adjacent the handle cannula joint which resulted in handle detachment from the device as stated in the event description, "inner catheter near the handle at the hand base got broken." even though the functional inspection could not be performed, kinks on the working length (extrusion and pull wire) can result in issues to extend and retract the brush properly; consequently, confirming the reported complaint.In addition, the brush section was cut.Marks in the cut end of the pull wire indicate that an unknown tool was used to cut the device.It is likely that the customer cut the brush section to obtain the samples taken during the procedure.As per complaint information the issue occurred during the procedure, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Also handling/manipulation factors could have contributed with the working length kinked and this condition can cause issues to extend/retract the brush due to friction between the components (extrusion/pull wire) at kinked areas.Continued attempts to extend/retract the brush can result in kinking the pull wire at handle cannula joint and force applied to the handle in order to extend/retract the brush can lead to the handle detachment from the device.A risk review of the rx cytology brush wireguided 8f 2.1mm was completed using the risk analysis workbook- biopsy brushes, bsc, av and confirmed that the event of "working length detachment of device or device component, brush retraction problem & brush difficult to extend" 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.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 the procedure during manufacturing, it is confirmed that the brush extends and retracts properly, if the unit does not extend/retract, it is scrapped.Also, it is confirmed that the thumb ring extends by pushing the handle in until it stops.It is also confirmed that the thumb ring retracts by pulling handle out until it stops.If the thumb ring is difficult to operate during brush extension or retraction, it is scrapped.These processes would have detected the encountered issues.Based on the information available and the analysis performed, the most probable root cause for this problem 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 during a procedure performed on (b)(6) of the brush, broke when using the cytology brush.In addition, it was also reported that the brush seemed hard to extend/retract from the beginning of usage.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 9437467
• MDR Text Key: 189763873
• Report Number: 3005099803-2019-05897
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0023928557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1