MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXCELON; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00564111
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hemoptysis (1887); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an excelon needle was used in the bronchus during a bronchoscopy procedure performed on (b)(6) 2023.During the procedure, the needle got stuck in the extended position.As the physician attempted to remove the scope with the needle, the needle detached from the device and needed to be retrieved.The needle was observed kinked when retrieved.At this time, it is unknown how the needle was retrieved.Reportedly, the device caused trauma to the surrounding tissue and a hemorrhage occurred.The physician administered adrenaline to the affected area and the patient was brought to the critical care unit for observation.The procedure was not completed successfully.The patient was admitted to the hospital beyond the standard of care.At this time, the patient has recovered and has no further complications.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of needle detachment.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf impact code f08 captures the reportable event of hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that an excelon needle was used in the bronchus during a bronchoscopy procedure performed on (b)(6) 2023.During the procedure, the needle got stuck in the extended position.As the physician attempted to remove the scope with the needle, the needle detached from the device and needed to be retrieved.The needle was observed kinked when retrieved.At this time, it is unknown how the needle was retrieved.Reportedly, the device caused trauma to the surrounding tissue and a hemorrhage occurred.The physician administered adrenaline to the affected area and the patient was brought to the critical care unit for observation.The procedure was not completed successfully.The patient was admitted to the hospital beyond the standard of care.At this time, the patient has recovered and has no further complications.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle detachment.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf impact code f08 captures the reportable event of hospitalization.Block h10: investigation results: the returned pulmonary biopsy needle was analyzed.The visual evaluation found that the working length presented many kinks along the extrusion and during the analysis it was observed that these kinks avoided the correct retraction and extension of the needle.No other problems were noted.The reported event was confirmed.Product analysis identified that it is most likely that user manipulation, some technique performed during procedure and/or even the anatomical factors encountered during the procedure may have contributed on this issue, once the working length presented these kinks the needle wouldn't be able to extended/retract.Based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure.A labeling review was performed and from the information available the device was used per the instructions for the use (ifu)/product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: EXCELON
• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16368239
• Report Number: 3005099803-2023-00205
• Device Sequence Number: 6926933
• Product Code: EOQ
• UDI-Device Identifier: 08714729456469
• UDI-Public: 08714729456469
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040018
• 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): 05/02/2023

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: 04/21/2025
• Device Model Number: M00564111
• Device Catalogue Number: 6411
• Device Lot Number: 0029270719
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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: Required Intervention
• Patient Sex: Unknown