MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CELLEBRITY; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Model Number	M00516010
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A cellebrity pulmonary cytology brush was received for analysis.Visual evaluation of the returned device revealed that the working length (sheath) was detached from the handle when received.In addition, the working length (sheath) was kinked in several locations and a kink was found near the handle cannula.During functional inspection, the handle was actuated, however the brush was not able to extend due to the damages observed on the device.As per complaint information the issue occurred during procedure, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to kink the working length (sheath).The kinks in the working length can cause friction between the components at kinked areas.The kinking of the device near the handle can cause that the handle cannula hits again the sheath at kinked area during handle actuation.Force actuating the handle can push out the sheath from handle and this would result in brush unable to be extended.Based on the information available and the analysis performed, the most probable root cause of the reported event is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.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 or Problem Description
It was reported to boston scientific corporation that a cellebrity pulmonary cytology brush was used in the lungs during a bronchoscopy with bronchial brushings procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the brush was able to extend from the sheath to take tissue samples.However, the brush failed to extend when they tried to put the specimen in the jar.The procedure was completed with another pulmonary cytology brush.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fine.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the working length (sheath) was detached from the handle when received.

• Brand Name: CELLEBRITY
• Common Device Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9398674
• Report Number: 3005099803-2019-05819
• Device Sequence Number: 381885
• Product Code: BTG
• UDI-Device Identifier: 08714729746249
• UDI-Public: 08714729746249
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K780872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: M00516010
• Device Catalogue Number: 1601S
• Device Lot Number: 0023288393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1