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 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual evaluation of the returned device found that the working length of the needle and sheath were kinked near the distal end of the handle and the distal section of the needle was also found to bent.Functional test was performed and the needle was able to extend and retract however, resistance was felt when the handle was actuated due to the kinked found in the device.The reported event of needle would not extend was confirmed.Due to operational and anatomical factors encountered during the procedure including the needle bent in the distal section, this condition limited the overall performance of the device causing resistance due to the friction between the needle and sheath during the handle actuation.Therefore, the most probable root cause classification for the reported failure is operational context.A dhr (device history record) review was performed and no deviation was 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 an expect pulmonary olympus needle device was used in the airway during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle would not actuate during the first pass.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 found that the distal section 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: 6385084
• MDR Text Key: 69277265
• Report Number: 3005099803-2017-00571
• 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: 02/16/2017

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: Physician
• 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: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1