MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564790

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex partially covered tracheobronchial stent was implanted during a metal stent placement procedure in the bronchi performed on (b)(6) 2015.According to the complainant, the stent was placed to treat a 1cm malignant lesion in the bronchi.Reportedly, the patient¿s anatomy was not tortuous and had not been dilated prior to the procedure.No visible issues were noted to the device prior to the procedure.During the procedure, the stent was successfully implanted; however, following deployment the physician reported that the stent cover was missing.No intervention was performed as a result of this event.The procedure was completed with this device.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 stable.

Manufacturer Narrative

(b)(4).A visual and functional examination of the complaint device could not be performed since the device was not returned for analysis.Given the event description, there isn't enough information to determine a probable root cause.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 other complaints exist for the specified batch.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: ULTRAFLEX? TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4565045
• MDR Text Key: 16543582
• Report Number: 3005099803-2015-00496
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2016
• Device Model Number: M00564790
• Device Catalogue Number: 6479
• Device Lot Number: 17064212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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: 59 YR
• Patient Weight: 65