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	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device found the working length of the needle and sheath were kinked at the distal end of the handle and the distal section of the needle was bent.Furthermore, the syringe luer at the handle was cracked.Functional test was performed by injecting water into the device however, water was leaking at the luer connection due to the crack.The reported event of luer damage was confirmed.Based on gathered information, it is most likely that the working length of the needle, sheath and distal section of the needle kinked due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause for the complaint event 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 similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that expect pulmonary olympus needle was used at station 7 of the patient's airway during an endobronchial ultrasound procedure performed on (b)(6) 2017.According to the complainant, during the procedure after several passes the respiratory therapist was unable to flush air through the needle.Leaking of air was heard at the top of the handle.Reportedly, bubbles were also visible and nothing was flushed out of the distal end of the needle.The procedure was completed with another of the same device.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.The investigation of the returned device found the distal tip 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: 6385030
• Report Number: 3005099803-2017-00572
• Device Sequence Number: 41719
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)20191130(10)19934622
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2017

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: Respiratory Therapist
• Device Expiration Date: 11/30/2019
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 19934622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/07/2017
• Patient Sequence Number: 1