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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 pulmonary cytology brush was used during a procedure on an unknown date.According to the complainant, during the procedure, after two passes of opening and closing, the sheath of the brush got broken.The wire popped out of the sheath from the top and they had to strip the sheath to get the brush out for the samples.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 9233471
• Report Number: 3005099803-2019-05096
• Device Sequence Number: 18935036
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: 05/01/2021
• Device Model Number: M00516151
• Device Catalogue Number: 1615
• Device Lot Number: 0023732248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/24/2019
• Patient Sequence Number: 1