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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
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BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number M00564740
Device Problems Difficult to Remove (1528); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/16/2014
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was being implanted in the bronchial tube during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat a malignant stricture in the main bronchi.During the procedure, the physician released the stent suture; however, it was noted that the stent failed to expand and would not release from the delivery system.The stent was caught in the delivery system when the delivery system was removed.The stent was removed with the delivery system from the patient.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.
 
Event Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was being implanted in the bronchial tube during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat a malignant stricture in the main bronchi.During the procedure, the physician released the stent suture; however, it was noted that the stent failed to expand and would not release from the delivery system.The stent was caught in the delivery system when the delivery system was removed.The stent was removed with the delivery system from the patient.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.
 
Manufacturer Narrative
(b)(4) for the reported event of stent failure to expand.(b)(4) for the reported event of catheter difficult to remove.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 visual examination of the returned device noted that it was received with the deployed stent positioned on the shaft of the delivery system.The deployment suture and pullring were not returned.No issues were noted with the stent length however, the stent was not fully expanded at the covered section.Measurements of the outer diameter (od) of the stent were taken and the maximum od was noted as 7mm and the minimum od was 4.7mm.Per product specification the stent diameter specification is 8.0mm ±1.5mm.The stent could not be removed from the shaft of the delivery device due to the stent not being fully expanded.The stent was equilibrated in 37°c water for 10 minutes and the stent expanded further so that it could be removed from the delivery device.The maximum stent od was measured as 7.17mm and the minimum od was 6.07mm after equilibrating in 37°c water.No issues were noted with the profile of the delivery device.Given the event description and condition of the returned device, 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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
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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 Key4151565
MDR Text Key4765181
Report Number3005099803-2014-03316
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
PMA/PMN Number
K012883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/16/2014
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 Date07/08/2015
Device Model NumberM00564740
Device Catalogue Number6474
Device Lot Number16218334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2014
Initial Date FDA Received10/08/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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