MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT MODEL B SINGLE USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00542751
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b scope was used on a bronchoscopy used to treat cystic fibrosis performed on (b)(6) 2023.During the procedure, the image stopped showing on the screen.The device was plugged in and out of the monitor.The procedure was successfully completed using another device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: block b5 has been edited to reflect additional details obtained via good faith effort.Block d7a has been modified to no.Block d9 has been corrected to yes and return to manufacturer date has been added.Block h3 device evaluated by manufacturer has been modified to no- device evaluation anticipated but not yet begun.Block h3 device return to manufacturer has been modified to yes.Block h8 has been modified to initial use.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b scope was used on a bronchoscopy performed in order to obtain a sample for the diagnosis of cystic fibrosis performed on (b)(6) 2023.During the procedure, when the scope was in the right main bronchus, the image stopped showing on the screen.The device was plugged in and out of the monitor.The procedure was successfully completed using another device.However, the sample could not be obtained.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h10: with all the available information, boston scientific concludes the most probable cause of the reported issue cannot be established.The returned exalt model b scope was connected to the capital equipment and the re-use error screen appeared.An endoscopic view was unable to be obtained.The reported event was confirmed.Electrical testing was performed, and no abnormalities were detected.The device usage log was reviewed.It showed that the device was used during the procedure and that it was either used more than once or that the time limit for usage had expired.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Based on a review of all available information, the cause of the reported event could not be determined.According to the device history record review, the device met all manufacturing specifications.Therefore, it is considered and isolated event with no clear established cause.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b scope was used on a bronchoscopy performed in order to obtain a sample for the diagnosis of cystic fibrosis performed on (b)(6) 2023.During the procedure, when the scope was in the right main bronchus, the image stopped showing on the screen.The device was plugged in and out of the monitor.The procedure was successfully completed using another device.However, the sample could not be obtained.There were no patient complications reported as a result of this event.

• Brand Name: EXALT MODEL B SINGLE USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18443308
• Report Number: 3005099803-2023-07044
• Device Sequence Number: 6883582
• Product Code: EOQ
• UDI-Device Identifier: 00191506007492
• UDI-Public: 00191506007492
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K211030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2024

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: 05/01/2024
• Device Model Number: M00542751
• Device Catalogue Number: 4275
• Device Lot Number: 0031291576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/24/2024; 04/05/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/14/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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