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

Model Number M00576300

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was used in the lungs during a stent placement procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the physician was able to pull the deployment suture all the way; however, the stent failed to expand and would not release from the catheter.The stent and the delivery system were removed from the patient.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.¿.

Manufacturer Narrative

A visual examination of the returned device found that the stent was partially deployed by 20mm.It was noted that the catheter shaft was kinked proximal 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 without issue.No issues were noted with the profile of the stent post deployment.The noted damages indicate difficulty was experienced during deployment and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was used in the lungs during a stent placement procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the physician was able to pull the deployment suture all the way; however, the stent failed to expand and would not release from the catheter.The stent and the delivery system were removed from the patient.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.¿.

Manufacturer Narrative

Reported event of stent failure to expand.The device has been received for analysis; however, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: 4207322
• MDR Text Key: 5185479
• Report Number: 3005099803-2014-03505
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2014

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: Physician
• Device Expiration Date: 03/25/2016
• Device Model Number: M00576300
• Device Lot Number: 0016846700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 10/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2014
• 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