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

Model Number	M00558250
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Premarket / 510(k) #: k163248 & k151895.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the lungs during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the distal tip of the needle was fractured and the metal part of the needle basically split in two and frayed out.The procedure was not completed successfully.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: 11396508
• Report Number: 3005099803-2021-00669
• Device Sequence Number: 19615988
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: 08714729861416
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• 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: 01/07/2024
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 0026596477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial 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