MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Cellebrity; Brush, Biopsy, Bronchoscope (Non-Rigid)

Model Number	M00516151
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity was to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During preparation, the device was opened and the seal was missing from the packaging.The procedure was completed with another device of the same model.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity was to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During preparation, the device was opened and the seal was missing from the packaging.The procedure was completed with another device of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4,h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted block h6 imdrf device code a020503 captures the reportable event of packaging seal compromised.
Additional Manufacturer Narrative
Block d4,h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h11: device evaluation the device was not returned for analysis; therefore, a technical analysis could not be performed.For this reason and due to the lack of evidence the reported event is unable to be confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.It was confirmed that the sterilization records associated with the lot were reviewed and found acceptable.No sterilization process deviations, anomalies, or nonconformances were identified that could have contributed to the reported event.Based on the information provided, the most probable cause of the reported event cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, no manufacturing deviations were identified that could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50484060
• Report Number: 3005099803-2026-03479
• Device Sequence Number: 13360978
• Product Code: BTG
• UDI-Device Identifier: 08714729014003
• UDI-Public: (01)08714729014003
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: M00516151
• Device Catalogue Number: M00516151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• 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
• Patient Sex: Unknown