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

Model Number	M00516011
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to be (b)(6), 2019 as no event date was reported.(b)(4).Investigation results: a cellebrity cytology brush was received for analysis.Visual inspection of the returned device revealed that the working length (sheath and wire) was broken from the handle and was kinked in several locations.In addition, it was observed that the distal section of the device was cut and the brush was not returned for analysis.It is most likely that the distal section (brush) was cut in order to collect the sample to be analyzed, therefore it is not considered as an issue of the device.No other issues were noted.Based on the event description the problem was noticed during procedure.Handling and manipulation of the device during its use can lead to working length (sheath and wire) kinks.The kinks in the working length can cause friction between the components that can lead to difficulty in extension or retraction of the brush due to the force applied in the handle.Moreover, continued movements applied to the handle can result to working length (sheath and wire) breakage.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Based on the information available and the analysis performed, the most probable root cause classification 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.
Event or Problem Description
It was reported to boston scientific corporation that a pulmonary cytology brush was used in the lungs during a biopsy procedure performed on an unknown date.According to the complainant, during the procedure and inside the patient, the nurse tried to open the cytology brush but the pull wire was broken just below the handle.The procedure was completed with another pulmonary cytology brush.There were no patient complications reported as a result of this event.The patient condition following 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 and wire) was found broken from the handle.

• 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: 9146457
• Report Number: 3005099803-2019-04701
• Device Sequence Number: 2802273
• Product Code: BTG
• UDI-Device Identifier: 08714729138990
• UDI-Public: 08714729138990
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/02/2019

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: 01/22/2021
• Device Model Number: M00516011
• Device Catalogue Number: 1601
• Device Lot Number: 0023231914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1