MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY; ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE

Model Number	M00558250
Medical Device Problem Codes	Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Premarket / 510(k) #: k163248 & k151895.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 expect pulmonary needle was used in the lymph node during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the physician attempted to obtain the specimen and it was seen on the ultrasound screen that the needle was bent.The device was removed from the scope and it was noticed that the distal tip was bent.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g5: premarket / 510(k) # : k163248 & k151895 block h6: imdrf medical device code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation results the returned expect pulmonary needle was analyzed, and a visual evaluation noted that the working length was kinked at the proximal and distal section of the device.The needle was also kinked.A functional evaluation noted that the needle was able to extend and retract without any issues when the handle was actuated.No other issues were noted.Based on all available information and the condition of the returned device, it is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Handling and manipulation of the device during the procedure can lead to kinking the device most likely when they tried to insert the unit into the scope.In addition, if the needle hits any hard surface or if there was any hard tissue it can result in needle bent/kinked.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.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the lymph node during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the physician attempted to obtain the specimen and it was seen on the ultrasound screen that the needle was bent.The device was removed from the scope and it was noticed that the distal tip was bent.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

• Brand Name: EXPECT PULMONARY
• Common Device Name: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11233430
• Report Number: 3005099803-2021-00205
• Device Sequence Number: 19654774
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: 08714729861416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 12/11/2023
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 0026503392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1