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 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: visual evaluation of the returned device revealed that the distal end of the needle was bent, the working length of needle and sheath was kinked near the distal end of the handle.Functional analysis showed that the needle was able to extend and retract with no issues.Complaint not confirmed.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

This report pertains to one of two complaint devices used during the same procedure.Manufacturer report # 3005099803-2017-00142, and 3005099803-2017-00143 for the other associated device information.It was reported to boston scientific corporation that two expect pulmonary endobronchial ultrasound transbronchial aspiration needle were used in the 4r lung during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2016.According to the complainant, during the procedure the needle was able to extend out of the scope but when the handle was actuated, the needle failed to advance out of the sheath.A second needle was used however the needle failed to advance out of the sheath.The procedure was completed with a third 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.The investigation found the distal tip of the needle was bent, this is now deemed an mdr reportable event.

Event Description

This report pertains to one of two complaint devices used during the same procedure.Manufacturer report # 3005099803-2017-00142, and 3005099803-2017-00143 for the other associated device information.It was reported to boston scientific corporation that two expect pulmonary endobronchial ultrasound transbronchial aspiration needle were used in the 4r lung during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2016.According to the complainant, during the procedure the needle was able to extend out of the scope but when the handle was actuated, the needle failed to advance out of the sheath.A second needle was used ;however, the needle failed to advance out of the sheath.The procedure was completed with a third 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.

• 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: 6303944
• MDR Text Key: 66607745
• Report Number: 3005099803-2017-00142
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)20191031(10)0019849518
• 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,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 0019849518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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