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 Type  malfunction  

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 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.

Manufacturer Narrative

Date of report updated.

Event 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
• 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: 6744472
• MDR Text Key: 81142081
• Report Number: 3005099803-2017-02071
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)20200430(10)20519864
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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