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 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The analysis of the returned expect pulmonary needle noted that the needle was retracted upon receipt and the syringe and stylet were not returned.A visual evaluation found the working length (sheath and needle) were kinked at the distal end of the handle and at 3.4 cm from the distal end of the needle.A functional evaluation found the needle was difficult to extend and retract.A lab reserve syringe was attached to the handle and air was compressed into the device.Air would not pass through.A lab reserve stylet was inserted into the device and could not advance through.The handle was disassembled, and it was discovered that the needle was bent within the handle.The complaint was 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.

Event Description

It was reported to boston scientific corporation that an expect pulmonary endobronchial ultrasound (ebus) transbronchial aspiration needle (tban) was used in the lungs during an ebus procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the needle was used to sample tissue from nodal station 4l.Upon attempted retrieval of the sample, the user was unable to expel the sample from the needle.The stylet was passed through the device to expel the sample, but it could not be advanced to the tip of the needle.Air, saline, and epinephrine were flushed through the needle, but the specimen could not be expelled.The procedure was completed with a different device.There were no patient complications as result of the event.The patient's condition at the conclusion of the procedure was reported to be fine.Investigation results revealed the distal end of the needle was bent; therefore, this is now 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: 5667988
• MDR Text Key: 45575338
• Report Number: 3005099803-2016-01388
• Device Sequence Number: 1
• Product Code: EOQ
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: M00558250
• Device Catalogue Number: 5825
• Device Lot Number: 18666013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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
• Patient Age: 65 YR