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

Model Number M00545000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the distal bile duct, during a biliary stent placement procedure performed on (b)(6), 2017.According to the complainant, during the procedure, when trying to perform second scraping cytology, the brush failed to advance through the scope.A newrx cytology brush was then opened and used to complete the procedure with no issues.After the procedure was completed, the physician evaluated the first rx cytology brush that was used, and confirmed that the bristled portion of the brush was bent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ¿no injury¿.

Manufacturer Narrative

A visual evaluation of the returned rx cytology brush presented residues which indicated use and handling.The brush was noted to be partially retracted when received.Further evaluation found that the working length (pull wire and extrusion) was kinked in several locations of the device, and the bristled portion of the brush was also found kinked.The tip of the brush was also found to be bent.A functional analysis was performed and revealed that severe resistance was encountered when the kinked part of the rx cytology brush was advanced through the scope.It is most likely that during the procedure the device could have been excessively manipulated so the device became kinked.The kinks found could have affected the device's insertion ability and its ability to advance through the scope.This failure directly impacts the performance of the product during use.Based on all gathered information, the most probable cause of this complaint is ¿operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure the performance of the device was limited.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the distal bile duct, during a biliary stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when trying to perform second scraping cytology, the brush failed to advance through the scope.A newrx cytology brush was then opened and used to complete the procedure with no issues.After the procedure was completed, the physician evaluated the first rx cytology brush that was used, and confirmed that the bristled portion of the brush was bent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ¿no injury¿.

• 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: 7157759
• MDR Text Key: 96235728
• Report Number: 3005099803-2017-03972
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 20964815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• 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