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

Model Number	2295-05
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a06 is being used to capture the reportable event of loss of visualization inside the patient.
Event or Problem Description
It was reported that an exalt model b monitor was used for a bronchoscopy procedure on an unknown date.It was observed that the exalt monitor would unexpectedly shut down.No patient complications related to this event were reported.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported that an exalt model b monitor was used for a bronchoscopy procedure on an unknown date.It was observed that the exalt monitor would unexpectedly shut down.No patient complications related to this event were reported.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a06 is being used to capture the reportable event of loss of visualization inside the patient.Block h11: with all the available information, boston scientific concludes that testing of the returned device identified that the monitor performed within specification.Examination of the monitor showed that the device was used without being properly charged.The power supply was returned and was noticed to be unused.The device instructions for use (ifu) state to ensure that the exalt monitor is sufficiently charged before use.Upon return, the device was thoroughly analyzed.The logs of the monitor were examined, and it was noticed that the device was used for 73 procedures.Multiple instances were found in which the monitor was used without being properly charged.The monitor was functionally tested and was found to perform within specifications.Based on all the available information, a conclusion code of no problem detected was assigned to this investigation.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.

• Brand Name: EXALT B MONITOR
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TRICE MEDICAL INC; 40 general warren blvd; suite 100; malvern PA 19355
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19163306
• Report Number: 3005099803-2024-01886
• Device Sequence Number: 20678078
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 08/27/2024

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 Model Number: 2295-05
• Device Catalogue Number: 2295-05
• Device Lot Number: 0022129001
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown