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); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
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 emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a pulmonary biopsy needle was planned to be used in the respiratory tract during a bronchoscopy procedure performed on (b)(6), 2020.According to the complainant, during preparation, the tip of the needle was detached from the device.The procedure was completed with another pulmonary biopsy needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on (b)(6), 2020.Block h6: device problem code 2907 captures the reportable event of the tip of the needle detached.Block h10: 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 emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a pulmonary biopsy needle was planned to be used in the respiratory tract during a bronchoscopy procedure performed on (b)(6), 2020.According to the complainant, during preparation, the tip of the needle was detached from the device.The procedure was completed with another pulmonary biopsy needle.There were no patient complications reported as a result of this event.**additional information received (b)(6), 2020** based on the photos received, it was noted that the needle was not detached but instead was damaged and constrained within the sheath.
Event or Problem Description
It was reported to boston scientific corporation that a pulmonary biopsy needle was planned to be used in the respiratory tract during a bronchoscopy procedure performed on (b)(6) 2020.According to the complainant, during preparation, the tip of the needle was detached from the device.The procedure was completed with another pulmonary biopsy needle.There were no patient complications reported as a result of this event.**additional information received (b)(6), 2020** based on the photos received, it was noted that the needle was not detached but instead was damaged and constrained within the sheath.
Additional Manufacturer Narrative
Block h6: device problem code 2907 captures the reportable event of the tip of the needle detached.Block h10: investigation results analysis of the returned device revealed that the needle was severely bent at the distal section and it was not detached, also the external sheath was not returned but the internal sheath was returned attached to the device.Based on the information available and the analysis performed, the severe bend in the needle was caused by some additional force applied.Since the issue occurred during the set up prior to the procedure, it is likely that handling and manipulation when they tried to release the unit from it's original package or when they tried to test the unit could have contributed to the encountered issues.Therefore, the most probable cause classification is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 10192471
• Report Number: 3005099803-2020-02460
• Device Sequence Number: 947603
• Product Code: EOQ
• UDI-Device Identifier: 08714729456452
• UDI-Public: 08714729456452
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K040018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2020

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: 12/10/2022
• Device Model Number: M00564101
• Device Catalogue Number: 6410
• Device Lot Number: 0024912268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 07/24/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/16/2020; 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1