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

Model Number M00564790

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was used in the right trachea during a stent placement procedure performed on an unknown date.During the procedure, the stent failed to deploy and the catheter was kinked.The stent was removed from the patient and the procedure was completed with another ultraflex tracheobronchial stent.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 good and stable.

Manufacturer Narrative

Investigation results of stent partially deployed investigation results: a visual examination of the returned device found that the stent was partially deployed by 15mm.It was noted that the catheter shaft was kinked both proximal and distal to the stent.No issues were noted with the crochet stitches from the point of release from the stent.During analysis it was possible to retract the deployment suture and fully deploy the stent with some bending of the shaft noted.The noted issue is likely due to procedural or anatomical factors encountered during the procedure such as tortuous anatomy or maneuvering of the device.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.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, ESOPHAGEAL
• 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: 4332821
• MDR Text Key: 5219499
• Report Number: 3005099803-2014-03930
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 11/25/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2015
• Device Model Number: M00564790
• Device Catalogue Number: 6479
• Device Lot Number: 16193161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2013
• 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