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

Model Number M00558250

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

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 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
• Type of Device: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6385030
• MDR Text Key: 69277892
• Report Number: 3005099803-2017-00572
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)20191130(10)19934622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1