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

Model Number	M00516011
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual analysis of the returned cellebrity cytology brush found that the yellow sheath was detached from the handle.Further evaluation noted that the proximal portion of the catheter was torn and the pull wire was kinked.There were no issues found on the handle or cannula.Functional evaluation could not be performed due to flare detachment.The complaint that the catheter was detached was confirmed.Therefore, the most probable root cause for this event is determined to be handling damage.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity cytology brush was opened for use during a cytology procedure performed on (b)(6) 2017.According to the complainant, during preparation, it was noted that the catheter was detached.The procedure was completed with another cellebrity cytology brush.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 good.

• Brand Name: CELLEBRITY¿
• Common Device Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6687101
• Report Number: 3005099803-2017-01938
• Device Sequence Number: 11202569
• Product Code: BTG
• UDI-Device Identifier: 08714729138990
• UDI-Public: (01)08714729138990(17)20190228(10)20285037
• Combination Product (Y/N): N
• PMA/510(K) Number: K780872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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: 02/28/2019
• Device Model Number: M00516011
• Device Catalogue Number: 1601
• Device Lot Number: 20285037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1