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

Model Number	M00516071
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a celebrity cytology brush was opened for use during a cytology procedure performed on (b)(6) 2018.According to the complainant, during preparation, when the device was checked, it was noticed that the wire inside the catheter broke and the brush failed to extend and retract.The procedure was completed with another celebrity 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: 7713866
• Report Number: 3005099803-2018-02406
• Device Sequence Number: 995696
• Product Code: BTG
• UDI-Device Identifier: 08714729139089
• UDI-Public: 08714729139089
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2018

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 Model Number: M00516071
• Device Catalogue Number: 1607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1