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

Model Number	M00516011
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Pneumothorax (2012); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04035 for the first cellebrity biopsy brush and 3005099803-2024-03937 for the second cellebrity biopsy brush.It was reported to boston scientific corporation that a cellebrity brush was used during a robotic bronchoscopy procedure performed on (b)(6) 2024.During the procedure, when deploying the brush, the sheath broke off at the handle and went forward into the patient, puncturing the lung.The patient experienced bleeding and a pneumothorax.Cold saline was applied, and a chest tube was placed.A second brush was used and broke when the brush was put on the microscope slide.The procedure was reported to be completed.The patient was hospitalized beyond the standard of care due to this event and was reported to have fully recovered.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf patient code e0734 captures the reportable event of pneumothorax.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf patient code e0506 captures the reportable event of hemorrhage major.Imdrf impact code f23 captures the intervention of chest tube.Imdrf impact code f08 captures the prolonged hospitalization.
Additional Manufacturer Narrative
Block h2 (additional information): updated content in b5 and h6 based on additional information received on august 20, 2024.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04035 for the first cellebrity biopsy brush and 3005099803-2024-03937 for the second cellebrity biopsy brush.It was reported to boston scientific corporation that a cellebrity brush was used during a robotic bronchoscopy procedure performed on (b)(6) 2024.During the procedure, when deploying the brush, the sheath broke off at the handle and went forward into the patient, puncturing the lung.The patient experienced bleeding and a pneumothorax.Cold saline was applied, and a chest tube was placed.A second brush was used and broke when the brush was put on the microscope slide.The procedure was reported to be completed.The patient was hospitalized beyond the standard of care due to this event and was reported to have fully recovered.No further information has been obtained despite good faith efforts.Additional information was received on august 20, 2024.It was reported that the second cellebrity used failed to extend the brush prior to being used in the procedure.A third brush was used to complete the procedure.
Additional Manufacturer Narrative
Block h2 (additional information): updated content in b5 and h6 based on additional information received on august 20, 2024.Block h11: the returned cellebrity cytology brush was analyzed, and a product analysis observed that the working length yellow tubing has been detached from the handle which doesn't allow the brush extension.Additionally, the working length and the wire from the brush are kinked right next to the handle.The brush was not returned.Media analysis found the yellow working length is detached from the handle in one of the devices.The reported event of brush difficult to extend is confirmed.Based on all available information, it is most likely that the working length kinked and detached happened as a result of the manipulation of the device during procedure.Depending on the technique used by the physician when introducing the device into the scope or the force applied when extending the brush could have affected the integrity of the working length, getting them kinked and subsequently detached.The brush was not returned.It is most likely that the brush was manually removed in order to obtain the samples from the procedure.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04035 for the first cellebrity biopsy brush and 3005099803-2024-03937 for the second cellebrity biopsy brush.It was reported to boston scientific corporation that a cellebrity brush was used during a robotic bronchoscopy procedure performed on (b)(6) 2024.During the procedure, when deploying the brush, the sheath broke off at the handle and went forward into the patient, puncturing the lung.The patient experienced bleeding and a pneumothorax.Cold saline was applied, and a chest tube was placed.A second brush was used and broke when the brush was put on the microscope slide.The procedure was reported to be completed.The patient was hospitalized beyond the standard of care due to this event and was reported to have fully recovered.No further information has been obtained despite good faith efforts.**additional information was received on august 20, 2024** it was reported that the second cellebrity used failed to extend the brush prior to being used in the procedure.A third brush was used to complete the procedure.

• Brand Name: CELLEBRITY
• Common Device Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20025161
• Report Number: 3005099803-2024-03937
• Device Sequence Number: 7364103
• Product Code: BTG
• UDI-Device Identifier: 08714729138990
• UDI-Public: 08714729138990
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K780872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2026
• Device Model Number: M00516011
• Device Catalogue Number: 1601
• Device Lot Number: 0033464566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 10/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/11/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female