MAUDE Adverse Event Report: ACQUIRE PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00552350
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Premarket / 510(k) #: k163248, k151895.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used on a 4r lymph node during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2021.During the procedure, the 4r lymph node was complicated to reach.The first pass with the acquire needle was successful.Then the physician switched to an olympus 20ga needle since he thought it would be easier for him, however, he still had difficulties.They went back to using the acquire needle which was already bent on the distal part of the needle.When he wanted to insert the needle on the sheath, the needle broke in the trachea.The broken piece of the needle was retrieved using biopsy forceps.The procedure was completed with the olympus 20ga needle.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g4: premarket / 510(k) #: k163248, k151895.Block h6: medical device problem code a0501 captures the reportable event of needle detachment.Block h10: investigation results: the returned acquire pulmonary needle was analyzed, and a visual evaluation noted that the needle was bent and broken.The working length was kinked and the broken part of the needle was not returned.Media inspection was performed with two pictures provided by the customer, one showing the distal end of the needle was broken off and the other showing the anatomy.A functional evaluation was performed, which noted that the needle could extended/retracted when the handle was actuated and the stylet could be removed and reinserted without problems.Lastly, a microscope inspection showed that the broken end of the needle had an irregular shape/bent.No other issues were noted.The reported complaint was confirmed.Based on all available information and the condition of the returned device, the needle was bent before the break, which could have lead to the needle breaking off.The bend could have been caused by some technique applied by the costumer during the procedure and/or some interaction within another device.The observed kinks through the working length may be related to user manipulation, some technique applied during procedure and/or some interaction with another device.Therefor the investigation concluded the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used on a 4r lymph node during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2021.During the procedure, the 4r lymph node was complicated to reach.The first pass with the acquire needle was successful.Then the physician switched to an olympus 20ga needle since he thought it would be easier for him, however, he still had difficulties.They went back to using the acquire needle which was already bent on the distal part of the needle.When he wanted to insert the needle on the sheath, the needle broke in the trachea.The broken piece of the needle was retrieved using biopsy forceps.The procedure was completed with the olympus 20ga needle.There were no patient complications reported as a result of this event.

• Brand Name: ACQUIRE PULMONARY
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• MDR Report Key: 12417619
• Report Number: 3005099803-2021-04401
• Device Sequence Number: 4724274
• Product Code: EOQ
• UDI-Device Identifier: 08714729986225
• UDI-Public: 08714729986225
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 05/26/2024
• Device Model Number: M00552350
• Device Catalogue Number: 5235
• Device Lot Number: 0027394760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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