MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXPECT PULMONARY OLYMPUS 25GA; ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE

Model Number	M00558250
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) investigation result: visual evaluation revealed that the distal end of the needle was slightly bent.Functional analysis revealed that the stylet could be removed and inserted without any issues.The device was able to create and hold vacuum.No sample residue was left in the device.The complaint was not confirmed.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification is operational context.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no other complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary endobronchial ultrasound transbronchial aspiration needle was used in the bronchial tube during an endobronchial ultrasound - transbronchial needle aspiration (ebus-tbna) procedure performed on (b)(6) 2017.According to the complainant, during the procedure there was difficulty puncturing the tissue and was unable to obtain a sample.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient had no complication at the conclusion of the procedure.The investigation found the distal end of the needle was bent, this is now deemed an mdr reportable event.

• Brand Name: EXPECT PULMONARY OLYMPUS 25GA
• Common Device Name: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6760392
• Report Number: 3005099803-2017-02219
• Device Sequence Number: 1490237
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)20191130(10)20013759
• Combination Product (Y/N): N
• PMA/510(K) Number: K151315
• 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
• Report Date (Section B): 07/13/2017

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: 11/30/2019
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 20013759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1