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

Model Number	M00516151
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2020 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
Note: this report pertains to one of ten devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 and 3005099803-2020-02815 for the associated device information.It was reported to boston scientific corporation that at least ten cellebrity cytology brushes were opened and used during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, the yellow sheathing that housed the brush was coming off where it meets the handle.When the catheter slid distally down towards the bristled portion of the brush, it prevented the brush from extending and working properly.Reportedly, it covered the brush when the handle was fully open.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 fine.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code 2907 captures the reportable event of working length detached/separated.Block h10: 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.Block h11: block b5 has been updated based on record review on 01sep2020.
Event or Problem Description
Note: this report pertains to one of ten devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-02805, 3005099803-2020-02806, 3005099803-2020-02807, 3005099803-2020-02808, 3005099803-2020-02809, 3005099803-2020-02810, 3005099803-2020-02812, 3005099803-2020-02813, 3005099803-2020-02814 and 3005099803-2020-02815 for the associated device information.It was reported to boston scientific corporation that at least ten cellebrity cytology brushes were opened and used during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, the yellow sheathing that housed the brush was coming off where it meets the handle.When the catheter slid distally down towards the bristled portion of the brush, it prevented the brush from extending and working properly.Reportedly, it covered the brush when the handle was fully open.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 fine.Update based on review september 01, 2020.Note: based on further review of the event, "yellow sheathing that housed the brush was coming off where it meets the handle", it was determined that the medical device report (mdr) was sent in error.The yellow sheathing detached at the device handle, outside the patient.The detachment of the sheath at this location could not fully fall in the patient requiring intervention for retrieval.This event did not, and could not, lead to a serious injury.There is no opportunity for the failure to cause a patient injury if it were to recur.This event does not meet medical device reporting criteria and is not considered a reportable event.

• 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: 10295138
• Report Number: 3005099803-2020-02810
• Device Sequence Number: 14061491
• Product Code: BTG
• UDI-Device Identifier: 08714729014003
• UDI-Public: 08714729014003
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 03/19/2022
• Device Model Number: M00516151
• Device Catalogue Number: 1615
• Device Lot Number: 0025378329
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1