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

Model Number M00545000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(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 used on (b)(6) 2019.According to the complainant, during the procedure, the catheter of the brush detached.It was noted that the movement of the brush became worse during usage.The procedure was then completed with a different device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: the initial reporter address is (b)(6) block d4, h4: the complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.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 device was returned with the handle detached (pull wire kinked and broken).In addition, a kink was observed in the working length at approximately 3.0 cm from the black heat shrink.As per complaint information the issue occurred during the procedure.It is most likely that the failures found (the pull wire kinked and broken and the working length kinked) were caused due to manipulation as the customer brushed back and forth during unpacking, prepping or testing.Handling and manipulation of the device can lead to bend the catheter and pull wire.This condition can cause difficulties to extend/retract the brush.The force applied to the handle in order to extend/retract the brush in addition to the kinks found can result to the broken pull wire at handle cannula joint.Continued movements of the handle can result with the handle cannula detached.A risk review of the biliary cytology 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 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 procedure during manufacturing it is confirmed that the brush extends and retracts properly, if the unit does not extend/retract, it is scrapped.Based on the information available and the analysis performed, the most probable root cause for this problem is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used on (b)(6) 2019.According to the complainant, during the procedure, the catheter of the brush detached.It was noted that the movement of the brush became worse during usage.The procedure was then completed with a different device.There were no patient complications reported as a result of this event.

• 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: 9382846
• MDR Text Key: 188576142
• Report Number: 3005099803-2019-05813
• 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: 01/08/2020

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 Model Number: M00545000
• Device Catalogue Number: 4500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1