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

Model Number	M00516011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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).Investigation results: visual evaluation of the returned celebrity cytology brush revealed that the catheter was kinked and torn near to the handle.Further evaluation noted that the pull wire was found kinked and broken with evidence of bending.Functional analysis showed that the brush failed to extend due to the condition of the returned device.Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and no deviations were found.
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.According to the complainant, during the procedure, the catheter was kinked and the brush failed to extend and retract.The procedure was completed with another celebrity cytology brush.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; wire broke.

• 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: 7087270
• Report Number: 3005099803-2017-03503
• Device Sequence Number: 11179846
• Product Code: BTG
• UDI-Device Identifier: 08714729138990
• UDI-Public: 08714729138990
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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): 11/10/2017

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: 03/31/2019
• Device Model Number: M00516011
• Device Catalogue Number: 1601
• Device Lot Number: 20420907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1