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

Model Number M00564830

Device Problems Positioning Problem (3009); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex tracheobronchial stent was used in the distal trachea during an endotracheal stenting procedure performed on (b)(6) 2015.According to the complainant, the stent was placed to treat a 4cm long and 10mm wide lesion due to tracheal stenosis.Reportedly, the patient¿s anatomy was not tortuous and the lesion had not been dilated prior to stent placement.There was no visible damage noted to the stent prior to the procedure.The stent was able to be deployed without issue.However, post deployment, a flexible scope was used to check the stent and they found that the stent had not fully expanded and had moved out of place.The stent was removed from the patient using forceps and the procedure was not completed due to this event.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

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) stent failure to expand.(b)(4) stent positioning/placement problem.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.

Manufacturer Narrative

A deployed ultraflex tracheobronchial stent was returned for analysis.The stent was not fully expanded at the covered section with a maximum od of 9.37mm in its midsection, which was below the product specification of 16.0mm ±1.5mm.It was also noted that the stent cover was hardened and plasticized in appearance.The stent was equilibrated in 37°c water for 23 minutes; however, the stent further expanded to a maximum of only 9.46mm in its mid section.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.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.

Event Description

It was reported to boston scientific corporation on (b)(4) 2015 that an ultraflex tracheobronchial stent was used in the distal trachea during an endotracheal stenting procedure performed on (b)(6) 2015.According to the complainant, the stent was placed to treat a 4cm long and 10mm wide lesion due to tracheal stenosis.Reportedly, the patient¿s anatomy was not tortuous and the lesion had not been dilated prior to stent placement.There was no visible damage noted to the stent prior to the procedure.The stent was able to be deployed without issue.However, post deployment, a flexible scope was used to check the stent and they found that the stent had not fully expanded and had moved out of place.The stent was removed from the patient using forceps and the procedure was not completed due to this event.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; 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: 4878949
• MDR Text Key: 16990191
• Report Number: 3005099803-2015-01799
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

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: 03/09/2016
• Device Model Number: M00564830
• Device Catalogue Number: 6483
• Device Lot Number: 16803488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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 Outcome(s): Required Intervention