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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 M00564760
Device Problems Kinked (1339); Difficult to Remove (1528); Positioning Problem (3009); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2015
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an ultraflex¿ tracheobronchial stent was implanted to treat a 3cm airway stricture in the right bronchus during a bronchoscopy with stent placement procedure performed on (b)(6) 2015.The lesion had been dilated in a previous procedure and the patient¿s anatomy was reported to be normal.According to the complainant, the ultraflex¿ tracheobronchial stent was placed into the patient¿s airway over a guidewire and the radiopaque markers were positioned under fluoroscopic guidance.The physician was pleased with the position and began to deploy the stent.There was initial resistance and difficulty felt in releasing the suture to deploy the stent.This prompted the physician to reposition the stent slightly more distally.The assisting nurse stated that the string felt ¿stuck¿ and ¿hard to move¿ during deployment.The stent was fully deployed after feeling intermittent resistance.The delivery system was held in place for approximately 2-3 minutes while the stent opened.The delivery system became caught on the distal end of the stent upon removal.The physician waited another 2-3 minutes before attempting to remove the delivery system again.It took some force to remove the delivery system and observation with the scope revealed that the stent had moved proximally out of position and appeared damaged.The stent was removed with reusable retrieval forceps and the physician noted that the stent was kinked at one end and not fully expanded.The delivery system also appeared significantly bent, just proximal to the proximal radiopaque marker.The procedure was completed with a different 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
(b)(4) stent failed to expand.(b)(4) stent positioning issue.(b)(4) stent kinked.(b)(4) difficulty removing catheter.The device has not been received for analysis.Upon receipt and 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.Device analysis determined that the condition of the returned device was consistent with the complaint incident as the stent was not fully expanded on return.No issues were noted with the stent length however, the stent was not fully expanded at the covered section with a maximum od of 6.81mm in its midsection.The expansion was also uneven as the stent was more expanded in its mid section than the ends of the stent cover.It was also noted that the stent cover was hardened and plasticized in appearance.The stent was equilibrated in 37°c water for 15 minutes.The stent did not expand any further measuring a maximum od of 6.92 mm in its mid section.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 similar 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.Based on the event description and condition of the returned device, a definitive root cause could not be determined.
 
Event Description
It was reported to boston scientific corporation that an ultraflex¿ tracheobronchial stent was implanted to treat a 3cm airway stricture in the right bronchus during a bronchoscopy with stent placement procedure performed on (b)(6) 2015.The lesion had been dilated in a previous procedure and the patient¿s anatomy was reported to be normal.According to the complainant, the ultraflex¿ tracheobronchial stent was placed into the patient¿s airway over a guidewire and the radiopaque markers were positioned under fluoroscopic guidance.The physician was pleased with the position and began to deploy the stent.There was initial resistance and difficulty felt in releasing the suture to deploy the stent.This prompted the physician to reposition the stent slightly more distally.The assisting nurse stated that the string felt ¿stuck¿ and ¿hard to move¿ during deployment.The stent was fully deployed after feeling intermittent resistance.The delivery system was held in place for approximately 2-3 minutes while the stent opened.The delivery system became caught on the distal end of the stent upon removal.The physician waited another 2-3 minutes before attempting to remove the delivery system again.It took some force to remove the delivery system and observation with the scope revealed that the stent had moved proximally out of position and appeared damaged.The stent was removed with reusable retrieval forceps and the physician noted that the stent was kinked at one end and not fully expanded.The delivery system also appeared significantly bent, just proximal to the proximal radiopaque marker.The procedure was completed with a different 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.
 
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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 Key4840278
MDR Text Key5942740
Report Number3005099803-2015-01623
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K012883
Number of Events Reported1
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 05/20/2015
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 Date02/22/2017
Device Model NumberM00564760
Device Catalogue Number6476
Device Lot Number17726906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/20/2015
Initial Date FDA Received06/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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