MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXPECT PULMONARY OLYMPUS 22GA; ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE

Model Number M00558220

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Visual evaluation of the device revealed that the distal section of the needle is slightly bent and broken.The broken section was separated and was not returned.The remaining section of the needle measured 3.5cm, indicating that an approximately 2.5cm section of the needle separated from the device.Functional analysis revealed that the needle would extend and retract.Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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.A labeling review was performed and no anomalies were found.

Event Description

It was reported to boston scientific corporation that an expect pulmonary olympus was used in the lung during a transbronchial needle aspiration (tbna) procedure performed on (b)(6) 2017.According to the complainant, during the procedure on the second biopsy, the complainant reported the that needle was unable to puncture.The device was removed from the scope and the tip of the needle was found to be detached.None of the fragments were found inside the scope.The procedure was completed with another of the same device.A ct scan was performed on (b)(6) 2017 but they were unable to confirm if any fragments were left inside the patient.

• Brand Name: EXPECT PULMONARY OLYMPUS 22GA
• 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: 6814294
• MDR Text Key: 83365648
• Report Number: 3005099803-2017-02542
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K151315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: M00558220
• Device Catalogue Number: 5822
• Device Lot Number: 20257776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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
• Patient Outcome(s): Required Intervention