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

Model Number	M00516151
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	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that a celebrity cytology brush was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when they pulled the product out of the package and upon insertion, the brush was detached from the sheath.The procedure was completed with another celebrity cytology brush.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity cytology brush was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when they pulled the product out of the package and upon insertion, the brush was detached from the sheath.The procedure was completed with another cellebrity cytology brush.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code 2907 captures the reportable event of brush break.Block h10: a cellebrity cytology brush was received for analysis.Visual analysis of the returned device revealed that the working length (sheath) was detached from the handle.Also, the working length (sheath and wire) were kinked in several locations, there was a severe kink at approximately 1.3cm from handle.In addition, the sheath was detached and the working length (pull wire) was kinked in some locations.No other issues were noted.The customer provided a picture of the device and it showed that the sheath of the cellebrity cytology brush, was detached and the working length (pull wire) was kinked in some locations.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 and wire).Kinks in the working length can cause friction between the components.Severe kinking near the handle can cause that the handle cannula to hit against the sheath during handle actuation, which can lead to the handle pushing out the sheath and therefore detaching it from the handle.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.

• 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: 8738967
• Report Number: 3005099803-2019-03066
• Device Sequence Number: 1341865
• Product Code: BTG
• UDI-Device Identifier: 08714729014003
• UDI-Public: 08714729014003
• 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,Followup
• Report Date (Section B): 07/31/2019

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: 02/10/2021
• Device Model Number: M00516151
• Device Catalogue Number: 1615
• Device Lot Number: 0023330724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 60