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

Model Number M00564910

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported to boston scientific corporation on september 19, 2016 that an ultraflex tracheobronchial stent was to be used to treat a benign stricture during a stent placement procedure performed on (b)(6) 2016.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.According to the complainant, during the procedure, the stent was able to be deployed inside the patient; however, it failed to fully expand.The stent was removed from the patient with the use of a forceps and the procedure was completed using 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 stable.

Manufacturer Narrative

Investigation results: an ultraflex tracheobronchial stent was received for analysis; the stent delivery system was not returned.The stent was fully expanded and the stent dimensions were within specifications.Based on the evaluation of the returned device, the complaint that the stent failed to expand was not confirmed.The returned device showed no evidence of either the alleged issue or any defect which could have contributed to the event.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 on september 19, 2016 that an ultraflex tracheobronchial stent was to be used to treat a benign stricture during a stent placement procedure performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was not tortuous and was not dilated prior to stent placement procedure.According to the complainant, during the procedure, the stent was able to be deployed inside the patient; however, it failed to fully expand.The stent was removed from the patient with the use of a forceps and the procedure was completed using 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 stable.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6029637
• MDR Text Key: 57427132
• Report Number: 3005099803-2016-03059
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K012883
• 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,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2018
• Device Model Number: M00564910
• Device Catalogue Number: 6491
• Device Lot Number: 18932055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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