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

Model Number	M00564101
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an excelon tbna needle was used in the lung during a trachea biopsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the distal portion of the needle fractured and detached inside the patient.The detached needle was removed from the patient using forceps.This procedure was not completed, because another excelon needle was not available for use.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device problem code 2907 captures the reportable event of needle detach.Block h10: investigation results.Investigation results: one pulmonary biopsy needle was received for analysis.During functional inspection the handle was actuated and it could be extended and retracted indicating the needle was not fractured.Visual assessment of the device identified residues from use.The luer was found broken from the handle and it was lodged in the syringe, also it was observed the luer was cracked.No other issues were noted.As per complaint information, the issue occurred during procedure.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Most likely the luer was cracked when syringe was attached to the handle.Too much tightening of syringe when attaching it to the handle could crack syringe luer, additionally a lot force applied attaching the syringe can also break the luer from the handle.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices and handled/manipulated in the field.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure, since the adverse event occured during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that an excelon tbna needle was used in the lung during a trachea biopsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the distal portion of the needle fractured and detached inside the patient.The detached needle was removed from the patient using forceps.This procedure was not completed, because another excelon needle was not available for use.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: EXCELON
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9197874
• Report Number: 3005099803-2019-04888
• Device Sequence Number: 409022
• Product Code: EOQ
• UDI-Device Identifier: 08714729456452
• UDI-Public: 08714729456452
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 10/10/2020
• Device Model Number: M00564101
• Device Catalogue Number: 6410
• Device Lot Number: 0021242804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 66