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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual evaluation revealed that the needle and sheath was kinked near the handle.In addition the distal end of the needle was bent.Functional analysis was performed and the knobs could be tightened and loosened without any issue.The complaint was not confirmed.Most likely, the way in which the device was handled during unpacking could have caused the device to kinked near the handle and distal section. therefore, the most probable root cause classification for the reported failure is handling damage.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 an expect pulmonary olympus was used in the lungs during an endobronchial ultrasound (ebus) procedure.According to the complainant, during unpacking the physician was unable to adjust the sheath.The procedure was completed with another expect pulmonary olympus.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.This event has been deemed a reportable event based on the investigation results.Needle distal tip bent.
Additional Manufacturer Narrative
Date of report updated.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary olympus was used in the lungs during an endobronchial ultrasound (ebus) procedure.According to the complainant, during unpacking the physician was unable to adjust the sheath.The procedure was completed with another expect pulmonary olympus.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.This event has been deemed a reportable event based on the investigation results.Needle distal tip bent.

• 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: 6744472
• Report Number: 3005099803-2017-02071
• Device Sequence Number: 19052980
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)20200430(10)20519864
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

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: 04/30/2020
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 20519864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1