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	06/14/2017
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary endobronchial ultrasound transbronchial aspiration needle was used in the lungs during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2017.According to the complainant, during the procedure while inserting the device into the scope, the needle was already bent.The procedure was completed with another expect pulmonary endobronchial ultrasound transbronchial aspiration needle.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 6687923
• Report Number: 3005099803-2017-01998
• Device Sequence Number: 16177640
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)20200507(10)20613521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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: 05/07/2020
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 20613521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1