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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 M00564540
Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4) stent deployment suture broken.(b)(4) stent partially deployed.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 (b)(6) 2015 that an ultraflex tracheobronchial distal release uncovered stent was to be used in the left bronchus during a bronchial stenting procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 5cm malignant stricture.During the procedure, after reaching the target area, the physician attempted to deploy the stent by pulling the finger ring three times; however, resistance was felt and the suture could not be released.The physician continued pulling and the stent was half deployed when the deployment suture broke.The partially deployed stent was removed from the patient and the procedure was completed with another ultraflex tracheobronchial distal release uncovered 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).
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex tracheobronchial distal release uncovered stent was to be used in the left bronchus during a bronchial stenting procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 5cm malignant stricture.During the procedure, after reaching the target area, the physician attempted to deploy the stent by pulling the finger ring three times; however, resistance was felt and the suture could not be released.The physician continued pulling and the stent was half deployed when the deployment suture broke.The partially deployed stent was removed from the patient and the procedure was completed with another ultraflex tracheobronchial distal release uncovered 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
An ultraflex¿ tracheobronchial stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent was partially deployed.The shaft was noted to be kinked at multiple locations.Also, the deployment suture was broken near the end of the handle and the end of the suture was frayed.Functional analysis found that it was not possible to deploy the stent using the pull ring since the deployment suture broke, however, it was possible to manually deploy the stent by pulling on the end of the broken deployment suture.No other issues were identified during the product analysis.Device analysis determined that the condition of the returned device was consistent with the complaint incident that the stent was partially deployed.The cause of the reported deployment difficulties was most probably due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause for this complaint is operational context.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex tracheobronchial distal release uncovered stent was to be used in the left bronchus during a bronchial stenting procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 5cm malignant stricture.During the procedure, after reaching the target area, the physician attempted to deploy the stent by pulling the finger ring three times; however, resistance was felt and the suture could not be released.The physician continued pulling and the stent was half deployed when the deployment suture broke.The partially deployed stent was removed from the patient and the procedure was completed with another ultraflex tracheobronchial distal release uncovered 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.
 
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Brand Name
ULTRAFLEX¿ TRACHEOBRONCHIAL
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5371545
MDR Text Key36245643
Report Number3005099803-2016-00021
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 company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2017
Device Model NumberM00564540
Device Catalogue Number6454
Device Lot Number0018030547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2015
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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